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 range18 Years – 85 Years

SexALL

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)

What they're measuring

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: up to 1 week before surgery

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 2 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 4 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 6 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 12 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 24 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 48 weeks postoperatively ( plus or minus 1 week)

Trial details

NCT IDNCT01228188

SponsorMilitary Institute od Medicine National Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

Contact for this trial

Jacek Robaszkiewicz, dr med.

+48 604597970 vectra@izet.pl

View on ClinicalTrials.gov More Macular Holes trials

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: up to 1 week before surgery

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 2 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 4 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 6 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 12 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 24 weeks postoperatively ( plus or minus 1 week)

Best-corrected visual acuity (BCVA), postoperative macular hole closure type

Timeframe: 48 weeks postoperatively ( plus or minus 1 week)