Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

Study Overview
=================
Brief Summary
-----------------
Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

Detailed Description
-----------------
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.

Official Title
-----------------
A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia

Conditions
-----------------
Retinoschisis, Macular Detachment, High Myopia

Intervention / Treatment
-----------------
* Procedure: Macular buckling
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter macular schisis macular retinal detachment evidence of posterior staphyloma on clinical examination Exclusion Criteria: severe macular scar macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant) prominent vitreomacular traction a history of vitrectomy or macular buckle intraocular active hemorrhage or inflammation any media opacity which precluded imaging or clinical evaluation of the macula

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buckle<br>Macular buckling and intraocular gas (C3F8) injection. | Procedure: Macular buckling<br>* Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.<br>|
| Active Comparator: Vitrectomy<br>Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8). | Procedure: Vitrectomy<br>* Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal re-attachment rate |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative best corrected visual acuity |  | 12 month | 
| Post-operative macular structure on optical coherance tomography |  | 12 month |