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

Glostrup University Hospital, Copenhagen

Status

Completed

Conditions

Idiopathic Macular Hole

Treatments

Procedure: macular hole operation

Study type

Interventional

Funder types

Other

Identifiers

NCT00302328

COMAH

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Volunteers

No Healthy Volunteers

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.