Early Vitrectomy for Macular Tractional Maculopathy

Seoul Retina Investigator Group

Status: Unknown

Conditions: Myopia, Degenerative

Treatments: Procedure: Early vitrectomy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01121978

SRIG #2

Details and patient eligibility

About

This study is designed to identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy.

Characteristics of this study is as below

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

Full description

Degenerative myopia is relatively common disorder, especially in Korean, Japanese and Chinese.

Choroidal neovascularization is well-noted cause of VA deterioration, but nowadays, with improvement of diagnostic tools, such as OCT, VA deterioration from myopic tractional maculopathy is being concerned as well.

But till now, the necessity of early vitrectomy on MTM is controversial. By now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. And the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins.

In this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female with impending macular hole(identified with OCT)
• Age: over 20 years
• Symptom duration < 6 Months
• Visual acuity on trial: more than 20/320 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
• Any evidence of atrophic change, scar or exudation on macula active intraocular inflammation
• History of intraocular surgery other than uncomplicated cataract extraction 3 months before
• Uncontrolled IOP > 25mmHg

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 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 or vision deterioration occurs

Early vitrectomy

Experimental group

Description:

Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling

Treatment:

Procedure: Early vitrectomy