PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Spain

Cataract Clinical Trial

— PHY2103  

Official title:

Multicentric Post-market Clinical Follow-Up (PMCF) Study to Investigate Rotational Stability, Clinical Outcomes and Patient Reported Outcomes After Implantation of a Monofocal Toric IOL

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04866719
• Other study ID #: PHY2103
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2103)

Description:

This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.

If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE.

The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens.

In total approx. 45 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days.

Subjects participating in the trial will attend a total of maximum 12 study visits over a period of 630-780 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, 330-420 days and 630-780 days postoperative visits). Subjects would have the option for unscheduled visits if required medically.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;

• Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;

• Regular corneal astigmatism (measured by a topographer);

• Corneal astigmatism =0.75 D and = 4.25 D (measured by an automatic keratometer) in one or both eyes;

• Capability to understand and sign an IRB approved informed consent form and privacy authorization;

• Clear intraocular media other than cataract;

• Dilated pupil size large enough to visualize IOL axis markings postoperatively;

• Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;

• Willing and able to conform to the study requirements.

Exclusion Criteria:

• Age of patient <50 years at the day of screening;

• Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic keratometer) in both eyes

• Irregular astigmatism (measured by a topographer);

• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);

• Subjects with AMD suspicious eyes as determined by OCT examination;

• Previous intraocular or corneal surgery;

• Traumatic cataract;

• Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;

• Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;

• Ocular hypertension, suspicious glaucoma or glaucoma;

• Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;

• Concurrent or previous (within 30 days) participation in another drug or device investigation;

• Clinically significant dry eye as determined by the investigator's judgement;

• Ocular surface disease (clinical symptoms or keratitis);

• Patients showing contraindications as listed in the current Instructions for use (IFU);

• Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).

In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:

• zonular instability;

• need for iris manipulation;

• capsular fibrosis or other opacity; and

• inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Lens Opacities

Intervention

Device:
• IOL implantation experimental
Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).

Locations

Country	Name	City	State
Spain	Oftalvist Alicante	Alicante
Spain	Miranza IMO Barcelona	Barcelona
Spain	Miranza IOA Madrid	Madrid
Spain	Oftalvist Juan Bravo	Madrid
Spain	Miranza Virgen de Luján	Sevilla
Spain	Oftalvist Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.	targomedGmbH

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Kretz FT, Breyer D, Klabe K, Hagen P, Kaymak H, Koss MJ, Gerl M, Mueller M, Gerl RH, Auffarth GU. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens. J Refract Surg. 2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01. — View Citation

McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure (IOP) measurement	The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Keratometry	Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op, 1 month postoperative, 6 months postoperative
Other	Biometry	Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op
Other	IOL power	The power of the implanted IOL must be recorded.	during surgery
Other	Target refraction	The target refraction given by the IOL calculator is documented. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	during surgery
Other	Fundus OCT	An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op, 6 months postoperative
Other	Pupil Size (photopic)	Photopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).; The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op, 6 months postoperative
Other	Pupil Size (mesopic)	Mesopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).; The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op, 6 months postoperative
Other	Manifest refraction	The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2018.	Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Uncorrected Distance Visual Acuity (UDVA) - monocular	UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Uncorrected Distance Visual Acuity (UDVA) - monocular mesopic	UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Uncorrected Distance Visual Acuity (UDVA) - binocular	UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Uncorrected Distance Visual Acuity (UDVA) - binocular mesopic	UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under mesopic conditions.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Corrected Distance Visual Acuity (CDVA) - monocular	CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.	Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Corrected Distance Visual Acuity (CDVA) - monocular mesopic	CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Corrected Distance Visual Acuity (CDVA) - binocular	CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Corrected Distance Visual Acuity (CDVA) - binocular mesopic	CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly under mesopic conditions.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Binocular Contrast Sensitivity under photopic light conditions	Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Binocular Contrast Sensitivity under mesopic light conditions	Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Binocular Contrast Sensitivity under photopic light conditions and using a glare source	Contrast Sensitivity under photopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Binocular Contrast Sensitivity under mesopic light conditions and using a glare source	Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.	6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Patient reported outcomes, Quality of Vision Questionnaire	Outcomes measures of a questionnaire to address subjective study outcomes and disturbance by photic phenomena. For this study, the validated and verified questionnaire Quality of Vision (QoV) will be used.; The QoV Questionnaire consists of a Rasch-tested, linear-scaled, 30-item instrument on three scales providing a QoV score in terms of symptom frequency, severity, and bothersome. It is suitable for measuring QoV in patients with all types of refractive correction, eye surgery, and eye disease that cause QoV problems [McAlinden, 2010]. The score ranges are 0 to 100 with smaller scales indicating better results.	Pre-Op, 6 months postoperative, 24 months postoperative
Other	Slitlamp examination - Corneal Status	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal Status	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Fundus examination with dilated pupil	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - Signs of inflammation	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: Signs of inflammation; Anterior chamber cells,; Anterior chamber flare,; Cystoid macular oedema,; Hypopyon, and; Endophthalmitis	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - Pupillary block	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Pupillary block	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - Retinal detachment	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Retinal detachment	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - Status of anterior and posterior capsule	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Status of anterior and posterior capsule	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - IOL decentration	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL decentration	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - IOL tilt	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL tilt	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - IOL discoloration	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL discoloration	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Slitlamp examination - IOL opacity	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.; With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL opacity	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Manual assessment of IOL axis position	IOL axis will be subjectively measured by the examiner during the slit lamp examination with dilated eyes. Only for the PODEYE toric implanted eyes.	within 10 minutes after surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	PCO grading	Posterior capsule grading should be performed after pupil dilation at the follow up visits mentioned in the examination matrix. The status of the posterior capsule should be noted to be either "intact" or "not intact". If the capsule is intact, the presence of PCO and/or Elschnig's pearls will be documented as "present" or "absent". If "present", the location and clinical significance of the finding will be documented. Posterior capsular opacification (PCO) will be graded using the following scale: 0: None; Minimal; Mild; Moderate; Severe	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Halo and Glare Scores (binocular)	A Halo and Glare simulator software (Eyeland Design Network GmbH, Germany) will be used to assess the subjective perception of photic phenomena. The patients will be asked to adjust the halo and glare level in a simulated image to the amount they perceive of such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes serve as a baseline measurement.; This simulator utilizes a scale for intensity, size of the halo, and glare that ranges from zero (none) to 100 (extremely disturbing). It also allows for classifying the halos into three types, as follows: T1 (diffuse halo ring), T2 (starburst type), and T3 (distinct halo ring) [Kretz, 2015].	Pre-Op, 6 months postoperative, 24 months postoperative
Other	Safety outcomes	The SPE rates of the investigational product will be compared to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2).; Rates of adverse events as determined by EN ISO 11979-7:2018 will be reported through the complete study follow-up. The proportion of all subjects with these events will be reported over time. Statistical comparisons to EN ISO 11979-7:2018 SPE (Safety and Performance Endpoints) rates (Annex E) will be based on all eyes implanted with the investigational device using a one-sided, exact test based on the binomial distribution.	Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other	Medication Revision	Prior to the study start, a standard medication will be defined that all patients will receive and that is standard for cataract surgery. Only changes to the standard concomitant medication will be documented in the CRFs.	Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Primary	Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation	The primary performance endpoint is to show statistically non-inferior rotational stability outcomes on PODEYE TORIC lens compared to CER data obtained for a multifocal toric IOL (POD FT) by the same manufacturer sharing the same haptic design but based on a hydrophilic lens material. The null hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is not larger than the absolute mean IOL rotation reported in the current CER on POD FT lens.; The alternative hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is larger than the outcomes reported in the current CER on POD FT lens. The measure is taken at 6 months postoperative visit compared to the measurement performed within 10 minutes after surgery.	6 months postoperative
Secondary	Best Corrected Distance Visual Acuity compared to historical Data	The objective is to compare CDVA above defined thresholds of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.3 and E.4). The null hypothesis for the CDVA is that / when the true rate of cases with visual acuity 0.3 logMAR or better is less than or equal to the SPE rate. The alternative hypothesis is that the "success" rate is higher than the SPE rate. If the distance corrected visual acuity is 0.3 logMAR or better in 30 eyes or more (with 36 eyes included), the null hypothesis could be rejected, and the alternative hypothesis could be accepted.	Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Secondary	Change in cylindrical Power of the Eye	Change in cylindrical power, defined as the difference between magnitude of preoperative keratometric cylinder and postoperative manifest cylinder is calculated at every Form. The outcomes of this calculation will be stratified per 0.25D step of preoperative keratometric cylinder and descriptive statistics (mean, standard deviation, median, minimum, maximum) will be provided.	Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative