NCT01121978

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

2 years

First QC Date

April 30, 2010

Last Update Submit

March 28, 2011

Conditions

Myopia, Degenerative

Keywords

macular tractional maculopathypathologic myopia

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual acuity

    48 weeks

Secondary Outcomes (1)

  • Rate of occurrence of full-thickness macular hole

    48 weeks

Study Arms (2)

Conservative treatment group

NO INTERVENTION

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

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

Procedure: Early vitrectomy

Interventions

Early vitrectomyPROCEDURE

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

Also known as: pars plana vitrectomy for macular tractional maculopathy
Early vitrectomy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 82-2-3010-3673, 138-736, South Korea

RECRUITING

Konyang University, Myung Gok Eye Research Institute

Daejeon, Daejeon, 302-718, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 463-707, South Korea

RECRUITING

HanGil Eye Hospital

Incheon, In Cheon, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

RECRUITING

Kangdong Sacred Heart Hospital, Hallym University College of Medicine,

Seoul, Seoul, 134-701, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

RECRUITING

Catholic University of Korea

Seoul, Seoul, 137-701, South Korea

RECRUITING

Gangnam Sacred Heart Hospital,Hallym University

Seoul, Seoul, 150-950, South Korea

RECRUITING

Kong eye clinic

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Se Woong Kang, M.D.

    Seoul Retina Investigator Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Se Woong Kang, M.D.

CONTACT

82-2-3410-6776swkang@skku.edu

Se Woong Kang

CONTACT

82234103562swkang@skku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 12, 2010

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2012

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

KR(10)