Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: Inverted ILM Repositioning


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idiopathic Full Thickness Macular Hole<br>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. | Procedure: Inverted ILM Repositioning<br>* Three port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. First a 0.6-1.0mm piece of ILM surrounding the macular hole is removed. Then significant margin of ILM in macular hole circumference is released while staying connected at the base to the macularrhexis border. Excess of ILM is trimmed. Perfluorocarbon is administrated, stabilizing ILM flap and facilitating the flap repositioning. Trypan Blue is used to stain the ILM. ILM flap is pressed down over the macular hole. The procedure is ended by SF6 gas tamponade. Even in absence of cataract formation, a combined procedure is performed because of exact peripheral vitreous shaving and prevention of cataract formation.<br>* Other names: ILM flap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | up to 1 week before surgery | 
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | 2 weeks postoperatively ( plus or minus 1 week) | 
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | 4 weeks postoperatively ( plus or minus 1 week) | 
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | 6 weeks postoperatively ( plus or minus 1 week) | 
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | 12 weeks postoperatively ( plus or minus 1 week) | 
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | 24 weeks postoperatively ( plus or minus 1 week) | 
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed. | 48 weeks postoperatively ( plus or minus 1 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | up to 1 week before surgery | 
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | 2 weeks postoperatively (plus and minus 1 week) | 
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | 4 weeks postoperatively (plus and minus 1 week) | 
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | 6 weeks postoperatively (plus and minus 1 week) | 
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | 12 weeks postoperatively (plus and minus 1 week) | 
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | 24 weeks postoperatively (plus and minus 1 week) | 
| Central Macular Thickness (CMT), Central Macular Volume | Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO). | 48 weeks postoperatively (plus and minus 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FTMH, PPV, inverted ILM repositioning