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Macular HoleNCT00737074

Macular Hole in Diabetic Retinopathy

An observational study of Macular Hole and Proliferative Diabetic Retinopathy, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
How many people
23 participants
Where
1 siteTaiwan
Study dates
Jan 2002to Dec 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Paitient with proliferative diabetic retinopathy

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Department of Ophthalmology, National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Macular Hole in Proliferative Diabetic Retinopathy With Fibrovascular Proliferation

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.

Read the detailed description

From January 2002 to December 2007 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation and the medical and surgical records are reviewed.

Diabetic fibrovascular proliferation associated with macular hole that had undergone pars plana vitrectomy with a minimum of 6 months of post-operative follow-up will be retrospectively reviewed. Cases fulfilling the indication criteria will be selected for the study All operations had been performed following the same principle and techniques.

Demographics and clinical findings of each case will be recorded including age, sex, involved eye, duration of macular hole, intraoperative diagnosis, extent of vitreo-retinal adhesion and detachment, morphology of macular hole, and relationship of macular hole to posterior hyaloid and fibrovascular proliferation. Data regarding treatment of macular hole, final opening or closure of macular hole, and duration of postoperative follow-up will also be compiled. Results of ophthalmological examinations, including pre- and post-operation best corrected visual acuity, intraocular pressure, and intravitreal tamponade material will be recorded. Optical coherence tomography (OCT) findings will be categorized and recorded. Retinal detachment severity will be classified as: no traction retinal detachment (TRD) or TRD within arcade (grade 1); TRD outside arcade, but not to or beyond the equator (grade 2); and RD extended to the periphery in at least 1 quadrant (grade 3). The degree of macular elevation surrounding the macular hole will be classified into three grades according to pre- or intra-operative observation: shallow: barely visible macular detachment with or without fine retinal folds and with underlying choroidal patterns still identifiable through the detached retina; moderate: obvious detachment with folds and loss of visualization of underlying choroidal patterns; and high: convex shaped or dome shaped detachment with wavy configuration in the macular area. Extent of fibrovascular proliferation will be separated into 3 grades: grade 1: focal adhesions only; grade 2: broad adhesion at more than 1 site or vitreous-retinal adhesion at disc, macula or arcade; and grade 3: vitreous-retinal attachment extending to the periphery.

Statistical Analysis To examine the significance of various clinical findings in relation to final macular hole closure rate, statistical analysis of the data is performed with chi-squared test or Fisher's exact test. To further verify the clinical characteristics and treatments that affecting macular hole closure, multivariate logistic regression analysis is performed to determine the significance of the following factors: age, sex, operation eye, duration of macular hole, RD extent, submacular fluid level, extent of fibrovascular proliferation, macular hole shape, and intravitreal tamponade materials. An association of post-operative best-corrected visual acuity with other study variables is assessed by multiple lineal regression analysis, using backward Wald's criteria, taking post-operation best-correted visual acuity as the dependent variable. All of the statistical analyses are performed using STATA 8.2 software (StataCorp LP, College Station, Texas, USA). A P value < 0.05 is considered statistically significant.

Keywords
Fibrovascular proliferation, Internal limiting membrane peeling, Macular detachment, Macular hole, Proliferative diabetic retinopathy.
Medical subject headings
Retinal Perforations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Final opening or closure of macular hole

    Measured: Six months

Secondary outcomes (1)
  1. Post-operation best corrected visual acuity

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2008 (estimated)
  2. Study startJan 2002
  3. Primary completionNov 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737074
Sponsor's protocol ID
200806056R
Status last verified
Aug 2008
First submitted
14 Aug 2008
Last updated
18 Aug 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Hole and Proliferative Diabetic Retinopathy, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final opening or closure of macular hole (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.

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