Clinical trial NCT01121978: Early Vitrectomy for Macular Tractional Maculopathy
Official title: Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia, Degenerative
Keywords: macular tractional maculopathy
pathologic myopia
Lead sponsor: Seoul Retina Investigator Group
Sponsor class: NETWORK
First posted: 2010-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best Corrected Visual acuity
timeFrame: 48 weeks
Secondary outcomes:
measure: Rate of occurrence of full-thickness macular hole
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
state: 82-2-3010-3673
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
city: Daejeon
country: Korea, Republic of
facility: Konyang University, Myung Gok Eye Research Institute
city: In Cheon
country: Korea, Republic of
facility: HanGil Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Gangnam Sacred Heart Hospital,Hallym University
city: Seoul
country: Korea, Republic of
facility: Kong eye clinic
Study officials:
affiliation: Seoul Retina Investigator Group
name: Se Woong Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: