Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

Study Overview
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Brief Summary
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The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered. Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.

Official Title
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A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

Conditions
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Idiopathic Macular Hole

Intervention / Treatment
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* Procedure: macular hole operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic macular hele stage 2 or 3. Duration of Symptoms ≤ 12 months. Visual acuity ≥ 34 ETDRS letters. Intraocular pressure ≤ 23 mmHg. Informed consent. Exclusion Criteria: Previous macular hole in project eye Macular pucker worse than a cellophane macular reflex. Previous surgery or disease in the eye affecting retinal function. Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a. Amblyopia i project eye.
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: macular hole operation no peeling<br> | |
| Active Comparator: Macular hole operation ICG peeling<br> | Procedure: macular hole operation<br>* macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling<br>|
| Experimental: Macular hole operation TB peeling<br> | Procedure: macular hole operation<br>* macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (ETDRS Letters) | Visual acuity measured as the number of ETDRS letters at last follow-up | Visual acuity at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic Success | closure of the macular hole evaluated on optical coherence tomography 3 (OCT3) | macular hole closure at 12 months | 
| Visual Field Defects | visual field defects measured on humphrey perimetry | 6 months |