Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes (NCT01228188) | Clinical Trial Compass
UnknownNot Applicable
Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes
Poland25 participantsStarted 2010-08
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of surgical treatment of FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in patients with a macular hole.
Who can participate
Age range
18 Years – 85 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:
* full-thickness macular hole with a minimum diameter exceeding 400 μm
* BCVA of 0,3 or worse in log MAR units (\<=70 ETDRS letter) and 1,6 or better in log MAR units (\>=5 ETRDS letter)
* 18 years of age
* Informed consent
Exclusion Criteria:
* eyes with previous vitreous surgery
* cystoid macular edema from any cause
* post traumatic macular hole
* macular hole associated with retinal detachment
* any other ocular reason which causes the lack of improvement after macular hole surgery (e.g pigmentary abnormalities, age-related macular degeneration, corneal scarring)
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
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Timeframe: up to 1 week before surgery
2
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Timeframe: 2 weeks postoperatively ( plus or minus 1 week)
3
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Timeframe: 4 weeks postoperatively ( plus or minus 1 week)
4
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Timeframe: 6 weeks postoperatively ( plus or minus 1 week)
5
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Timeframe: 12 weeks postoperatively ( plus or minus 1 week)
6
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Timeframe: 24 weeks postoperatively ( plus or minus 1 week)
7
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Trial details
NCT IDNCT01228188
SponsorMilitary Institute od Medicine National Research Institute