Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

Macular Holes Clinical Trial

Official title: Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

• NCT number: NCT01228188
• Study type: Interventional
• Source: Military Institute of Medicine, Poland
• Contact: Jacek Robaszkiewicz, dr med.
• Phone: +48 604597970
• Email: vectra@izet.pl
• Status: Recruiting
• Phase: N/A
• Start date: August 2010
• Completion date: August 2013