Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

Not Applicable

• Conditions: Macular Holes
• Interventions: Procedure: Inverted ILM Repositioning

• Registration Number: NCT01228188
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief 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.

Detailed Description

At present, the anatomical closure rate of macular hole is around 90% using pars plana vitrectomy with ILM peeling. Improvement of visual acuity is around 80% including stage II to IV. With macular hole greater than 400 μm there is higher risk of surgical failure and visual acuity is usually less than 0.2. Large macular holes are more likely to have flat-open type closure, which is anatomical success but has limited improvement in visual acuity. Inverted ILM repositioning will form a scaffold for glial cells, which allows their migration and proliferation. This process will close the macular hole and secure it from re-opening, and will reduce the risk of flat-open type of closure.

The aim of this study is to estimate the efficiency and safety of inverted ILM repositioning in the treatment of macular hole with a minimum diameter exceeding 400 μm and compare results with the currently used methods of surgical large macular holes treatment.

Study Timeline

• Study Start: 2010-08
• Status Verified: 2010-09
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-25
• Last Update Submitted: 2010-10-25
• Study First Posted: 2010-10-26
• Last Update Posted: 2010-10-26
• Primary Completion: 2012-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Idiopathic Full Thickness Macular Hole	Inverted ILM Repositioning	Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs with a minimum diameter exceeding 400 um.

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity (BCVA), postoperative macular hole closure type	48 weeks postoperatively ( plus or minus 1 week)	BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.

Secondary Outcome Measures

Name	Time	Method
Central Macular Thickness (CMT), Central Macular Volume	48 weeks postoperatively (plus and minus 1 week)	Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

Trial Locations

Locations (1)

Military Institute of Medcine; 🇵🇱 Warsaw, ul. Szaserów 128, Poland