Early Vitrectomy for Macular Tractional Maculopathy

Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121978

Enrollment

Registered

2010-05-12

Start date

2009-11-30

Completion date

2012-11-30

Last updated

2011-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Degenerative

Keywords

macular tractional maculopathy, pathologic myopia

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.

Interventions

PROCEDUREEarly vitrectomy

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Best Corrected Visual acuity	48 weeks

Secondary

Measure	Time frame
Rate of occurrence of full-thickness macular hole	48 weeks

Countries

South Korea

Contacts

Primary ContactSe Woong Kang, M.D.

swkang@skku.edu82-2-3410-6776

Backup ContactSe Woong Kang

swkang@skku.edu82234103562

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026