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

Not Applicable

Completed

• Conditions: Idiopathic Macular Hole
• Interventions: Procedure: macular hole operation

• Registration Number: NCT00302328
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-14
• Primary Completion: 2008-01
• Study Completion: 2009-01
• Results First Submitted: 2012-10-04
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-13
• Last Update Submitted: 2014-03-13
• Results First Posted: 2014-04-16
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macular hole operation ICG peeling	macular hole operation	-
Macular hole operation TB peeling	macular hole operation	-

Primary Outcome Measures

Name	Time	Method
Visual Acuity (ETDRS Letters)	Visual acuity at 12 months	Visual acuity measured as the number of ETDRS letters at last follow-up

Secondary Outcome Measures

Name	Time	Method
Anatomic Success	macular hole closure at 12 months	closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
Visual Field Defects	6 months	visual field defects measured on humphrey perimetry

Trial Locations

Locations (1)

Department of Ophthalmology, Glostrup Hospital; 🇩🇰 Copenhagen, Denmark