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

Idiopathic Macular Hole Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302328
• Other study ID #: COMAH
• Status: Completed
• Phase: N/A
• First received: March 13, 2006
• Last updated: March 13, 2014
• Start date: August 2005
• Est. completion date: January 2009

Study information

• Verified date: March 2014
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Macular Hole
• Retinal Perforations

Intervention

Procedure:
• macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Glostrup Hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Danish Eye Health Society, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity (ETDRS Letters)	Visual acuity measured as the number of ETDRS letters at last follow-up	Visual acuity at 12 months	No
Secondary	Anatomic Success	closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)	macular hole closure at 12 months	No
Secondary	Visual Field Defects	visual field defects measured on humphrey perimetry	6 months	No