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.
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
- Conditions the study is for
- Macular Hole, Proliferative Diabetic Retinopathy
- 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
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.
- Conditions
- Macular Hole, Proliferative Diabetic Retinopathy
- 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.
Final opening or closure of macular hole
Measured: Six months
Secondary outcomes (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.
- First posted18 Aug 2008 (estimated)
- Study startJan 2002
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chung-May Yang, MD, Principal investigator, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Hole in Proliferative Diabetic Retinopathy With Fibrovascular Proliferation
- ClinicalTrials.gov ID
- NCT00737074
- Acronym / sponsor ID
- 200806056R
- Conditions
- Macular Hole, Proliferative Diabetic Retinopathy
- Keywords
- Fibrovascular proliferation, Internal limiting membrane peeling, Macular detachment, Macular hole, Proliferative diabetic retinopathy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitient with proliferative diabetic retinopathy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Final opening or closure of macular hole
Time frame: Six months
1 secondary outcome
Post-operation best corrected visual acuity
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-May Yang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.