Z8 OCT-controlled 2D vs 3D LASIK (NCT04426175) | Clinical Trial Compass
CompletedNot Applicable
Z8 OCT-controlled 2D vs 3D LASIK
Germany13 participantsStarted 2019-12-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictability of central flap thickness in OCT-controlled 110 µm LASIK