Status:
COMPLETED
Z8 OCT-controlled 2D vs 3D LASIK
Lead Sponsor:
Zentrumsehstarke Hamburg
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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 hyp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04426175
Start Date
December 5 2019
End Date
April 23 2020
Last Update
June 11 2020
Active Locations (1)
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1
Zentrumsehstärke
Hamburg, Germany, 20251