This study compares the 2-year outcomes of horizontal versus vertical scleral tunnel orientation in flanged intrascleral intraocular lens (IOL) fixation surgery. The primary outcome is the proportion of eyes achieving refraction within ±0.50 diopters of the target at 2 years. Secondary outcomes include IOL tilt measured by anterior segment optical coherence tomography (AS-OCT), iris capture, conjunctival erosion, and other complications. The study aims to determine whether tunnel orientation is associated with differing outcomes in this surgical technique.
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:
* Age ≥ 18 years
* Complicated aphakia defined as absence of adequate capsular support following cataract extraction, lens trauma, or previous lensectomy
* Crystalline lens luxation defined as partial or complete displacement of the natural lens due to zonular weakness
* Intraocular lens (IOL) luxation defined as partial or complete dislocation of a previously implanted IOL
* Inadequate capsular support (\<180° of intact zonular or capsular support)
* Ability to complete scheduled follow-up visits
* Complete follow-up data available
Exclusion Criteria:
* Previous scleral buckling surgery within 6 months
* Pars plana vitrectomy within 3 months
* Active uveitis
* Active endophthalmitis
* Uncontrolled scleritis or scleral thinning
* Corneal decompensation (endothelial cell density \<1000 cells/mm²)
* Uncontrolled glaucoma (IOP \>25 mmHg despite maximum therapy)
* History of penetrating keratoplasty, DALK, DSEK, or DMEK
* History of corneal refractive surgery
* Active proliferative diabetic retinopathy
* Pregnancy or breastfeeding
* Inability to complete 24-month follow-up
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
Proportion of Eyes Achieving Mean Absolute Error (MAE) Within ±0.50 Diopters of Target Refraction