NCT00556244

Brief Summary

Internal limiting membrane peeling in diabetic vitrectomy will help prevent postoperative epiretinal membrane formation

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 P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

April 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
Last Updated

November 9, 2007

Status Verified

April 1, 2007

First QC Date

November 8, 2007

Last Update Submit

November 8, 2007

Conditions

Patients With Proliferative Diabetic Retinopathy Who Have Active Fibrovascular Proliferation

Outcome Measures

Primary Outcomes (1)

  • Snellen BCVA and epiretinal membrane formation measured with OCT

    within 6 months after the surgery

Secondary Outcomes (1)

  • central macular thickness measured bt OCT

    within 6 months after the surgery

Study Arms (1)

2

ACTIVE COMPARATOR
Procedure: ILM peeling

Interventions

ILM peelingPROCEDURE

ILM maculorhexis is initiated using scraper and completed using a 25-gauge Synergetics (St. Louis, MO) forceps.

2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active fibrovascular proliferation with or without tractional detachment
  • previous pan-retinal photocoagulation at least 3 months before

You may not qualify if:

  • biomicroscopic evidence of macular hole
  • combination of tractional and rhegmatogenous retinal detachment
  • location of fibrovascular proliferation anterior to the equator
  • major ocular surgery history(including, scleral buckle, glaucoma filter, cornea transplant, vitreoretinal surgery etc
  • the presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, Taiwan

RECRUITING

Study Officials

  • Chung-may Yang, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-yao Chang, M.D.

CONTACT

886-2-23123456peiyao@seed.net.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

April 1, 2007

Study Completion

November 1, 2007

Last Updated

November 9, 2007

Record last verified: 2007-04

Locations

TW(1)