Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

Military Institute od Medicine National Research Institute

Status: Unknown

Conditions: Macular Holes

Treatments: Procedure: Inverted ILM Repositioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01228188

BW1127/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Idiopathic Full Thickness Macular Hole

Experimental group

Description:

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.

Treatment:

Procedure: Inverted ILM Repositioning