CClinicalTrials.gg
Status unknownNCT01121978Updated Mar 29, 2011

Early Vitrectomy for Macular Tractional Maculopathy

An interventional study of Early vitrectomy in Myopia, Degenerative, sponsored by Seoul Retina Investigator Group. Status unknown at 10 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-03-29.

Sponsored by Seoul Retina Investigator Group · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Myopia, Degenerative

Keywords

  • macular tractional maculopathy
  • pathologic myopia
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Seoul Retina Investigator Group is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

    Procedure: Early vitrectomy

Interventions

  • ProcedureEarly vitrectomy

    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

06

What researchers measure

Primary outcomes

  1. Best Corrected Visual acuity

    Time frame: 48 weeks

Secondary outcomes

  1. Rate of occurrence of full-thickness macular hole

    Time frame: 48 weeks

07

Study locations

10 of 10 sites recruiting
  • Asan Medical Center, University of Ulsan College of Medicine
    Seoul, 82-2-3010-3673 138-736, Korea, Republic of
    • Young Hee Yoon, M.D. · Contact · 82-2-3010-3673
    • Young Hee Yoon, M.D. · Principal investigator
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam, Gyunggi-do 463-707, Korea, Republic of
    • Kyu Hyung Park, M.D · Contact · jiani4@snu.ac.kr · 82-31-787-7373
    • Kyu Hyung Park, M.D · Principal investigator
    Recruiting
  • Konyang University, Myung Gok Eye Research Institute
    Daejeon, 302-718, Korea, Republic of
    • Jong Woo Kim, M.D. · Contact · 82-42-600-8816
    • Jong Woo Kim, M.D. · Principal investigator
    Recruiting
  • HanGil Eye Hospital
    In Cheon, Korea, Republic of
    • Joonhong Sohn, M.D. · Contact · 0325033322
    • Joonhong Sohn, M.D. · Principal investigator
    Recruiting
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
    • Hum Chung, M.D. · Contact · 82-2-2072-2437
    • Hum Chung, M.D. · Principal investigator
    Recruiting
  • Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
    Seoul, 134-701, Korea, Republic of
    • Sung Pyo Park, M.D. · Contact · 82-2-2224-2274
    • Sung Pyo Park, M.D. · Principal investigator
    Recruiting
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
    • Se Woong Kang, M.D. · Contact · swkang@skku.edu · 82-2-3410-3562
    • Se Woong Kang, M.D. · Principal investigator
    Recruiting
  • Catholic University of Korea
    Seoul, 137-701, Korea, Republic of
    • Won-Ki Lee, M.D. · Contact · 82-2-2258-2846
    • Won-Ki Lee, M.D. · Principal investigator
    Recruiting
  • Gangnam Sacred Heart Hospital,Hallym University
    Seoul, 150-950, Korea, Republic of
    • Ha Kyoung Kim, M.D. · Contact · 82-2-829-5193
    • Ha Kyoung Kim, M.D. · Principal investigator
    Recruiting
  • Kong eye clinic
    Seoul, Korea, Republic of
    • Eun Goo Lee, M.D. · Contact · 02-480-5000
    • Eun Goo Lee, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01121978
Lead sponsor
Seoul Retina Investigator Group
First posted
May 12, 2010
Start date
Nov 2009
Primary completion
Nov 2011 (estimated)
Completion
Nov 2012 (estimated)
Last update
Mar 29, 2011

Study contacts

Se Woong Kang, M.D.
Contact
swkang@skku.edu
82-2-3410-6776
Se Woong Kang
Contact
swkang@skku.edu
82234103562
Se Woong Kang, M.D.
principal investigator · Seoul Retina Investigator Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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