Comparative Analysis of Large Macular Hole Surgeries

Study Overview
=================
Brief Summary
-----------------
This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.

Detailed Description
-----------------
Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.

Official Title
-----------------
Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: the Cover group
* Procedure: the Fill group
* Procedure: the peeling group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy. Exclusion Criteria: High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the peeling group<br>the internal limiting membrane was discarded | Procedure: the peeling group<br>* the internal limiting membrane was discarded<br>|
| Experimental: the Cover group<br>the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer. | Procedure: the Cover group<br>* The internal limiting membrane around the MH was left to cover the hole<br>|
| Experimental: the Fill group<br>the internal limiting membrane was folded in multiple layers and deliberately stuffed or packed within the MH defect using a forceps. | Procedure: the Fill group<br>* The internal limiting membrane around the MH was left to fill the hole<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MH status | MH status (open, flat open or closed) | at 3 months after surgery | 
| IS/OS line interruption width | IS/OS line interruption width were gauged with spectral-domain optical coherence tomography | at 3 months after surgery | 
| Change from Baseline IS/OS line interruption width at 3 months | IS/OS line interruption width were gauged with spectral-domain optical coherence tomography | at 3 months after surgery | 
| Baseline best-corrected visual acuity | best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis | at 3 months after surgery | 
| Change from Baseline best-corrected visual acuity at 3 months | best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis | at 3 months after surgery | 
| visual function | visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25) | at 3 months after surgery | 
| Change from Baseline visual function at 3 months | visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25) | at 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inverted Internal Limiting Membrane Flap Technique, Large Macular Hole, Macular hole surgery