Anterior Versus Posterior Artisan Intraocular Lens Fixation in Aphakic Children With Insufficient… (NCT06396156) | Clinical Trial Compass
CompletedNot Applicable
Anterior Versus Posterior Artisan Intraocular Lens Fixation in Aphakic Children With Insufficient Capsular Support.
Egypt32 participantsStarted 2022-01-01
Plain-language summary
The Artisan lens (Artisan Aphakic, Ophtec BV) is an iris- claw lens designed for implantation in children with insufficient capsular support. In spite of less surgical manipulations and a relatively shorter operation time, the procedure carries the risk of corneal endothelial cell loss or dis-enclavation, particularly in children. However, most of the studies that studied iris-claw lenses in aphakic children were retrospective evaluated only a single technique; either anterior or retropupillary fixation, or comparable to other techniques of fixation. Thus the aim of this work is to prospectively compare the 2 techniques of iris-claw lens implantation and their effects on central endothelial cell density, the anatomical and visual outcome, as well as the complications' rate.
Who can participate
Age range
2 Years – 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:
* Hereditary lens subluxation that requires lensectomy and intraocular lens implantation.
* Traumatic lens subluxation that requires lensectomy and intraocular lens implantation.
* Microspherophakia that requires lensectomy and intraocular lens implantati
* Aphakia with insufficient capsular support.
Exclusion Criteria:
* Preoperative central endothelial cell density (CECD) less than 2500 cells/mm2
* Preoperative anterior chamber depth (ACD) less than 3 mm.
* Severely damaged iris.
* History of uveitis or glaucoma.
* Macular lesions or previous retinal 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.