Clinical Outcomes of an New EDOF IOL (Isopure®)

Cataract Clinical Trial

Official title:

Visual Outcomes and Patient Satisfaction After the Implantation of Isopure Extended-Depth-of-Focus Intraocular Lens (EDOF-IOL), With a Mini-Monovision Target

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05704686
• Other study ID #: Iso123
• Status: Completed
• Start date: April 26, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Vista Alpina Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.

Description:

This single-center retrospective study investigates visual outcomes and patient satisfaction in subjects bilaterally implanted with Enhanced-Depth of Focus (EDOF) Isopure® IOL during routine bilateral cataract surgery.

The study is carried out in an ophthalmic clinic in Switzerland. In this study, routine surgical techniques and postoperative follow-up will be applied as for all other (non-study) cataract patients in the clinic. Therefore, all study patients will be operated in immediate consecutive bilateral mode (routine in clinic). Patients participating in this study will be recruited and enrolled postoperatively. They undergo routine postoperative follow-up examinations, and data are collected at the third scheduled examination (4 to 6 weeks after surgery) and at a telephone call 4 to 6 months after surgery.

Isopure 1.2.3 is a CE certified intraocular lens readily available on the market in Switzerland.

The primary outcome consists in demonstrating a preserved distance visual acuity while improving binocular spectacle-free intermediate vision and, to a lesser extent, near vision. Binocular defocus curves are measured for each participant to simulate visual acuity at different distances. Patient satisfaction with treatment and subjective ratings of visual phenomena will be assessed using a modified PRISQ questionnaire and a modified NEI quality of vision questionnaire (RQL-42) at the third postoperative visit and three months after surgery.

At Vista Alpina Eye Clinic, mini-monovision is routinely used to further improve binocular intermediate and near vision while preserving the quality of distance vision in patients implanted bilaterally with EDOF Isopure® IOLs. Analysis of the retrospective data should help support this surgical strategy.

Patients with astigmatism up to 1.5 D benefit intraoperatively from Opposite Clear Corneal Incisions (OCCI) to reduce astigmatism. Analysis of our retrospective data will allow comparison of their visual performance with that of patients without astigmatism who did not require an additional OCCI procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;

• Patient's willingness to participate in the study;

• Capacity to understand and sign an informed consent form and comply with examination procedures;

• Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);

• Regular total corneal astigmatism =1.5 D (measured by topography method)

Exclusion Criteria:

• Cooperation difficulties (distance from home, general health conditions, cognitive impairment);

• Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);

• Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);

• History or presence of macular edema;

• Perioperative complications;

• Congenital, uveitic, traumatic or surgically-complicated cataract

• Regular total corneal astigmatism >1.5 dioptres (measured by topography method)

• Irregular cornea, including keratotomy

Related Conditions & MeSH terms

• Cataract
• Lens Opacities
• Pseudophakia

Intervention

Device:
• Isopure 1.2.3 intraocular EDOF lens implantation
Bilateral Isopure 1.2.3 intraocular EDOF IOL implantation during a routine cataract surgery.

Locations

Country	Name	City	State
Switzerland	Vista Alpina Eye Clinic	Visp

Sponsors (1)

Lead Sponsor	Collaborator
Kristof Vandekerckhove, MD, MBA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of OCCI on residual refractive cylinder	Residual refractive cylinder in eyes undergoing OCCI (eyes with preoperative topographic total corneal astigmatism 0.6 - 1.5 diopters), compared to eyes not having undergone OCCI (preoperative topographic cylinder 0 - 0.5 diopters).	4-6 weeks postoperatively
Other	Impact of OCCI on uncorrected binocular visual acuity	Comparison of binocular UDVA between three subgroups. Subgroup 1: both eyes having undergone OCCI. Subgroup 2: one eyes having undergone OCCI. Subgroup 3: none of the eyes having undergone OCCI.	4-6 weeks postoperatively
Other	Impact of OCCI on uncorrected monocular visual acuity	Comparison of monocular UDVA between eyes having undergone OCCI and eyes not having undergone OCCI (eyes with emmetropic objective only)	4-6 weeks postoperatively
Other	Accuracy of different IOL-formulas	Comparing various IOL-formulas used to calculate the appropriate IOL power during preoperative assessment. The objective is to determine which IOL formulas are most accurate, overall, and (subgroups) in function of the anatomy of the eye (short vs long eyes, shallow versus deep anterior chamber)	4-6 weeks postoperatively
Primary	UDVA(m)	Monocular Uncorrected Distance Visual Acuity	4-6 weeks postoperatively
Primary	CDVA(m)	Monocular Corrected Distance Visual Acuity	4-6 weeks postoperatively
Primary	UDVA(b)	Binocular Uncorrected Distance Visual Acuity	4-6 weeks postoperatively
Primary	UIVA	Binocular Uncorrected Intermediate Visual Acuity (80 cm)	4-6 weeks postoperatively
Primary	UNVA	Binocular Uncorrected Near Visual Acuity (40 cm)	4-6 weeks postoperatively
Primary	Defocus curve	Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.	4-6 weeks postoperatively
Secondary	Patient satisfaction with the visual outcome	(modified) PRISQ questionnaire	4-6 weeks postoperatively and 4-6 months postoperatively
Secondary	Subjective rating of visual phenomena	(modified) NEI quality of vision questionnaire (RQL-42, questions 17 and 38)	4-6 weeks postoperatively and 4-6 months postoperatively