Early Vitrectomy for Impending Macular Hole

Seoul Retina Investigator Group

Status: Unknown

Conditions: Retinal Perforation

Treatments: Procedure: Pars plana vitrectomy with ILM peeling

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01121965

SRIG #1

Details and patient eligibility

About

This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.

Full description

In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.

Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.

Characteristics of this study is as below

• Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)
• Non-randomized study (decision was made by patients after full explanation)
• After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated

Enrollment: 60 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female with impending macular hole(identified with OCT)
• Age: over 45 years
• Symptom duration < 6 Months
• Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart

Exclusion criteria

• Any vision disturbing disease other than impending macular hole
• Diabetic maculopathy or other retinal vascular disease
• Prior history of major trauma: If symptom begins after trauma
• Myopia over -6.5Dioper or eyes with axial length > 28mm
• Evidence of scar, degeneration or exudation of macula
• active intraocular inflammation
• History of intraocular surgery other than uncomplicated cataract extraction 3months before
• Uncontrolled IOP > 25mmHg

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conservative treatment group

No Intervention group

Description:

Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs

Early vitrectomy

Experimental group

Description:

Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.

Treatment:

Procedure: Pars plana vitrectomy with ILM peeling