Z8 OCT-controlled 2D vs 3D LASIK

Myopia Clinical Trial

Official title:

Precision of 2D vs 3D Low Energy Femto-LASIK: Intraoperative and Postoperative OCT-based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426175
• Other study ID #: CPFEM-0007-DE
• Status: Completed
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: April 23, 2020

Study information

• Verified date: June 2020
• Source: Zentrumsehstarke Hamburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of life responses during the early postoperative period.

Description:

It has been postulated that it is possible with the Ziemer Femtosecond LDV laser system to create reproducible flaps in terms of thickness and predictability. The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications. Patient-reported outcomes are increasingly incorporated into clinical trials as they provide access to valuable information on the physical experience of the patient during and after the treatment. A questionnaire will therefore also be introduced in this study to evaluate how well self-reported pain, visual experience, and quality of life responses are correlated with flap geometries in both groups during the early postoperative period. The study holds direct medical benefit to the patient in this that they received an immediate improvement in his/her unaided vision. Moreover, the patient's participation contributes to the medical knowledge about the use of femtosecond lasers for refractive surgery, in particular in view of the use of intraoperative OCT visualization tools. The patients will gain access to the newest technology available for refractive surgery namely a low pulse energy high-frequency femtosecond laser.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Key inclusion criteria as described by the German Commission for Refractive Surgery (KRC) are:

• The recommended range of application for the correction of myopia is up to -8.00 D and for the correction of astigmatism up to 5.00 D.

• The limited for LASIK correction of myopia is up to -10.00 D and correction of astigmatism up to 6.00 D. If myopic astigmatism is to be corrected, the values for myopia and astigmatism must be added together.

• The recommended range for correction of hyperopia is up to 3.00 D. Up to 4.00 D is the range of limited application for hyperopia.

• Age =18 years with stable eyesight for over 12 months.

Exclusion Criteria:

Key exclusion criteria as described by the German Commission for Refractive Surgery (KRC):

• preoperative corneal thickness less than 480 µm

• predicted stromal thickness under the flap after ablation of less than 250 µm

• chronic progressive corneal disease and forme fruste keratoconus

• surgery before the age of 18 years

• symptomatic cataract

• Glaucoma with a marked loss of visual field

• Exudative macular degeneration.

• Concurrent participation in another ophthalmological clinical study

Exclusion criteria irrespective of the KRC criteria:

• Undergone former eye surgery

• Contact lens wear within the two weeks prior to commencement of preoperative measurements

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting
2D and 3D cutting methods were randomly used in same subjects

Locations

Country	Name	City	State
Germany	Zentrumsehstärke	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Zentrumsehstarke Hamburg

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Eldaly ZH, Abdelsalam MA, Hussein MS, Nassr MA. Comparison of Laser In Situ Keratomileusis Flap Morphology and Predictability by WaveLight FS200 Femtosecond Laser and Moria Microkeratome: An Anterior Segment Optical Coherence Tomography Study. Korean J Ophthalmol. 2019 Apr;33(2):113-121. doi: 10.3341/kjo.2018.0035. — View Citation

Huhtala A, Pietilä J, Mäkinen P, Uusitalo H. Femtosecond lasers for laser in situ keratomileusis: a systematic review and meta-analysis. Clin Ophthalmol. 2016 Mar 7;10:393-404. doi: 10.2147/OPTH.S99394. eCollection 2016. — View Citation

Pajic B, Vastardis I, Pajic-Eggspuehler B, Gatzioufas Z, Hafezi F. Femtosecond laser versus mechanical microkeratome-assisted flap creation for LASIK: a prospective, randomized, paired-eye study. Clin Ophthalmol. 2014 Sep 22;8:1883-9. doi: 10.2147/OPTH.S68124. eCollection 2014. — View Citation

Pietilä J, Huhtala A, Mäkinen P, Salmenhaara K, Uusitalo H. Laser-assisted in situ keratomileusis flap creation with the three-dimensional, transportable Ziemer FEMTO LDV model Z6 I femtosecond laser. Acta Ophthalmol. 2014 Nov;92(7):650-5. doi: 10.1111/aos.12333. Epub 2013 Dec 26. — View Citation

Pietilä J, Huhtala A, Mäkinen P, Uusitalo H. Flap characteristics, predictability, and safety of the Ziemer FEMTO LDV femtosecond laser with the disposable suction ring for LASIK. Eye (Lond). 2014 Jan;28(1):66-71. doi: 10.1038/eye.2013.244. Epub 2013 Nov 15. — View Citation

Porela-Tiihonen S, Kaarniranta K, Kokki M, Purhonen S, Kokki H. A prospective study on postoperative pain after cataract surgery. Clin Ophthalmol. 2013;7:1429-35. doi: 10.2147/OPTH.S47576. Epub 2013 Jul 15. — View Citation

Tomita M, Chiba A, Matsuda J, Nawa Y. Evaluation of LASIK treatment with the Femto LDV in patients with corneal opacity. J Refract Surg. 2012 Jan;28(1):25-30. doi: 10.3928/1081597X-20111213-01. Epub 2011 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictability of central flap thickness in OCT-controlled 110 µm LASIK	Analyze central flap thickness in OCT-controlled 110 µm LASIK and to report on intended versus achieved flap thickness of one group with a 2D flap geometry in one eye and another group with a 3D flap geometry in the contralateral eye. All OCT measurements will be done in micron metres (µm).	1 month postoperatively
Secondary	Comparison of intraoperative flap thickness with pre- and postoperative results	Measurement of corneal thickness pre flap creation (Corneal Pachymetry measurements expressed in µm indicate the thickness of the cornea before flap was created. This measurement will serve as the baseline measurement. Pachymetry measured again after the flap was created and lifted by means of optical and ultrasonic pachymetry(µm) for both groups and to be compare with postoperative AS-OCT measurements also measured in µm.This will indicate how accurate the intraoperative flap thickness compare to the 1 week and 1 month thickness measurements as swelling and inflammatory processes could influence postoperative measurements.	1 week, 1 month
Secondary	Postoperative planarity	Assessment of several measurements taken along the corneal cut on superior, nasal, inferior and temporal points in order to compare the uniformity of the cut between 2D vs 3D geometries. Measurments will be done by means of AS-OCT,measured in µm units.Measurements at two different follow up periods will be analyzed and compared in order to rule out the role that inflammation could possibly play.	1 week, 1 month
Secondary	Intraoperative flap morphology	Observations that are defined by different scales in order to report on important features pertaining to 2D and 3D intraoperative flap geometries eg. the presence and extent of opaque bubble layer (OBL), ease of flap lifting and stromal bed quality in both groups . Intraoperative flap morphology assessment to be done as soon as the flap was created in terms of presence of an opaque bubble layer (no OBL, 30-40% of flap surface, >40% of flap surface). Once the flap was lifted to report on ease of flap lifting (easy/sticky/can not lift) and to describe the stromal bed quality (smooth,tissue bridges, rastered, lines).	During surgery
Secondary	Postoperative flap properties	Evaluate flap properties by means of slit lamp biomicroscopy examination. The flap`s visual appearance seen with the slit lamp to be described and documented as per the suggested scales during 2 specified follow up visits in terms of edge quality and visibility (`yes/no` If yes= extreme fine line, distinct line or irregular edge), border shape (round, irregular) and interface quality (smooth, lines, cobblestones, grids, microstriae) and be compared between flap geometries (2D and 3D flaps).	1 week, 1 month
Secondary	Visual outcomes	Compare pre- and postoperative visual acuity (UDVA, CDVA) measurements by means of a Snellen Visual Acuity chart and be expressed in decimal that will be converted to logMar units for the purpose of statistical analysis.	1 day, 1 week, 1 month
Secondary	Patient reported Outcomes: early recovery period	Conduct a non validated Patient Reported Outcome (PRO) questionnaire adopted and based on the `Brief Pain Inventory` questionnaire [Porela-Tiihonen] to assess patient`s early visual perceptions and pain experience related to their own functional status and wellbeing and to compare between the two eyes since each undergone different cutting geometry (2D vs 3D) methods.	1 day, 2Day, 1 week follow up
Secondary	Complications	Report and document any intra- and postoperative complications that may occur during the time of the procedure or at the 1 month follow up visit.	Intra- and postoperatively up to 1 month follow up