Early Vitrectomy for Macular Tractional Maculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Seoul Retina Investigator Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul Retina Investigator Group
ClinicalTrials.gov Identifier:
NCT01121978
First received: April 30, 2010
Last updated: March 28, 2011
Last verified: March 2011

April 30, 2010
March 28, 2011
November 2009
November 2011   (final data collection date for primary outcome measure)
Best Corrected Visual acuity [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01121978 on ClinicalTrials.gov Archive Site
Rate of occurrence of full-thickness macular hole [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Vitrectomy for Macular Tractional Maculopathy
Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia, Degenerative
Procedure: Early vitrectomy
Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
Other Name: pars plana vitrectomy for macular tractional maculopathy
  • No Intervention: Conservative treatment group
    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
  • Experimental: Early vitrectomy
    Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
    Intervention: Procedure: Early vitrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Se Woong Kang, M.D. 82-2-3410-6776 swkang@skku.edu
Contact: Se Woong Kang 82234103562 swkang@skku.edu
Korea, Republic of
 
NCT01121978
SRIG #2
Yes
Se Woong Kang, Samsung Medical Center
Seoul Retina Investigator Group
Not Provided
Principal Investigator: Se Woong Kang, M.D. Seoul Retina Investigator Group
Seoul Retina Investigator Group
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP