Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope (NCT06966622) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope
40 participantsStarted 2025-08-25
Plain-language summary
Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.
Who can participate
Age range
18 Years – 40 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:
* Clinical diagnosis of high myopic
* Aged 18-40 years
* Desire to improve their refractive status via ICL surgery
* Relatively stable refractive error (change ≤ 0.50 D per year for two consecutive years)
* Central anterior chamber depth ≥ 2.8 mm
* Open angles
* Corneal endothelial cell density ≥ 2000 cells/mm2.
Exclusion Criteria:
* Cataracts
* Corneal diseases,
* Glaucoma,
* Nystagmus,
* Strabismus,
* Lens subluxation,
* Severe vitreoretinal diseases,
* Other ocular diseases
* A history of ocular trauma
* A history of ocular surgery
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
b-wave amplitude
Timeframe: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op