Early Vitrectomy for Macular Tractional Maculopathy

Myopia, Degenerative Clinical Trial

Official title:

Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01121978
• Other study ID #: SRIG #2
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2010
• Last updated: March 28, 2011
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: March 2011
• Source: Seoul Retina Investigator Group
• Contact: Se Woong Kang, M.D.
• Phone: 82-2-3410-6776
• Email: swkang[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia, Degenerative

Intervention

Procedure:
• Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling

Locations

Country	Name	City	State
Korea, Republic of	Konyang University, Myung Gok Eye Research Institute	Daejeon
Korea, Republic of	HanGil Eye Hospital	In Cheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul	82-2-3010-3673
Korea, Republic of	Catholic University of Korea	Seoul
Korea, Republic of	Gangnam Sacred Heart Hospital,Hallym University	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital, Hallym University College of Medicine,	Seoul
Korea, Republic of	Kong eye clinic	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul Retina Investigator Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual acuity		48 weeks	No
Secondary	Rate of occurrence of full-thickness macular hole		48 weeks	No