Early Vitrectomy for Macular Tractional Maculopathy
- Conditions
- Myopia, Degenerative
- Interventions
- Procedure: Early vitrectomy
- Registration Number
- NCT01121978
- Lead Sponsor
- Seoul Retina Investigator Group
- Brief Summary
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
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early vitrectomy Early vitrectomy Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
- Primary Outcome Measures
Name Time Method Best Corrected Visual acuity 48 weeks
- Secondary Outcome Measures
Name Time Method Rate of occurrence of full-thickness macular hole 48 weeks
Trial Locations
- Locations (10)
Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
HanGil Eye Hospital
🇰🇷In Cheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
🇰🇷Seoul, 82-2-3010-3673, Korea, Republic of
Konyang University, Myung Gok Eye Research Institute
🇰🇷Daejeon, Korea, Republic of
Kong eye clinic
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyunggi-do, Korea, Republic of
Gangnam Sacred Heart Hospital,Hallym University
🇰🇷Seoul, Korea, Republic of