Comparing Posterior Release Sclerotomy With Conventional Evisceration Surgery.
Egypt80 participantsStarted 2024-05-01
Plain-language summary
The primary objective of this interventional study is to compare posterior release sclerotomy in the scleral cup with conventional ball implantation during evisceration, focusing on intraoperative feasibility, postoperative outcomes, and implant stability.
Specific objectives include:
1. Assessing the rate of implant migration and extrusion.
2. Evaluating the long-term stability of the implant within the scleral shell.
3. Investigating the occurrence of complications such as exposure or infection.
4. Analyzing the functional and anatomical outcomes.
5. Comparing patient satisfaction and quality of life measures.
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:
* Aged 18 years or older
* Indication for evisceration due to a non-malignant cause, such as painful blind eye, severe ocular trauma, end-stage glaucoma, or phthisis bulbi
* Adequate scleral integrity to allow for ball implantation
* No history of previous intraocular surgery or scleral weakening disorders
Exclusion Criteria:
* Orbital malignancy or suspected intraocular tumor
* Active ocular or periocular infection
* History of radiation therapy to the orbit
* Severe scleral thinning that contraindicates scleral preservation
* Presence of autoimmune disease affecting wound healing
* Psychiatric disorders affecting compliance with postoperative care
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
• Implant extrusion/migration rate within 6 months
Timeframe: Through study completion, an average of 6 months