NCT00737074

Brief Summary

Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation may have unique features. Internal limiting membrane peeling facilitates hole closure only in cases with shallow macular detachment. Final vision is associated with preoperative visual acuity and degree of macula elevation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
Last Updated

August 18, 2008

Status Verified

August 1, 2008

Enrollment Period

5.8 years

First QC Date

August 14, 2008

Last Update Submit

August 15, 2008

Conditions

Macular HoleProliferative Diabetic Retinopathy

Keywords

Fibrovascular proliferationInternal limiting membrane peelingMacular detachmentMacular holeProliferative diabetic retinopathy.

Outcome Measures

Primary Outcomes (1)

  • Final opening or closure of macular hole

    Six months

Secondary Outcomes (1)

  • Post-operation best corrected visual acuity

    Six months

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Paitient with proliferative diabetic retinopathy

You may qualify if:

  • From January 2002 to December 2007 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation and the medical and surgical records are reviewed.
  • Indications for surgery had been the severe complications of diabetic retinopathy and not the mere presence of macular hole alone.
  • Macular hole is found either preoperatively or during operation.
  • All cases are included in the study have attached retina postoperatively.

You may not qualify if:

  • Cases with recurrent rhegmatogenous detachment or post-operative dense cataract without lens extraction.
  • Follow-up duration of patients less than 3 months .
  • Incomplete medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Chung-May Yang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 18, 2008

Study Start

January 1, 2002

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

August 18, 2008

Record last verified: 2008-08

Locations

TW(1)