Proliferative Diabetic RetinopathyNCT00737022
Macular Appearance After Diabetic Vitrectomy
An observational study of Proliferative Diabetic Retinopathy and Vitrectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vitrectomy is one of the major treatment methods for complications of diabetic retinopathy. As surgical techniques and instruments improve, high anatomical success may be achieved; however, functional results are less favorable. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Vitrectomy
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2005to Dec 2006
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Proliferative diabetic retinopathy
Who may be able to join
- From June 2008 to December 2008 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation are included in our study.
- All cases have fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond equator in more than one quadrant.
- Complete removal of the visible posterior preretinal membrane must be done during surgery in every case.
- All cases are included in the study have attached retina postoperatively.
Who cannot join
- Cases with rhegmatogenous detachment, silicone oil infusion, or post-operative moderate to dense cataract are excluded.
- Patients are unable to follow-up regularly are not included.
- Patient refuses to join our study.
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 Appearance After Diabetic Vitrectomy for Fibrovascular Proliferation -An Optical Coherence Tomography Study
Vitrectomy is one of the major treatment methods for complications of diabetic retinopathy. As surgical techniques and instruments improve, high anatomical success may be achieved; however, functional results are less favorable. Despite attached retina, postoperative visual function may be affected by various macular and disc abnormalities. Major changes include optic atrophy, atrophic retina, poor macular perfusion, and structural alternations of the macula. Funduscopy, fluorescein angiography, and, more recently, optical coherence tomography (OCT) can be used to detect and document these alterations. Although fluorescein angiography is valuable in the assessment of various macular lesions as well as retinal vascular abnormalities, its usefulness in evaluating macular changes is limited in eyes that have undergone diabetic vitrectomy. The quality of the images may be compromised by mild diffuse hyperfluorescence in the posterior pole in middle and late phase angiography, which obscures capillary detail and subtle macular changes. Furthermore, quantification of changes may not be possible. Recently, optical coherence tomography has become very useful for the detection of vitreomacular abnormalities. The examination is noninvasive, can qualify the changes and detect subtle abnormalities not evident with other imaging studies.
In this study, OCT was applied to investigate how common macular structure abnormalities are present after surgery for complications of diabetic retinopathy, and how they may affect visual prognosis.
Read the detailed description
From June 2008 to December 2008 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation were included in the study.
All cases have fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond equator in more than one quadrant. Complete removal of the visible posterior preretinal membrane was done during surgery in every case. All cases included in the study had attached retina postoperatively. Cases with rhegmatogenous detachment, silicone oil infusion, or post-operative moderate to dense cataract were not included. Surgical indications included progressive fibrovascular proliferation (FVP), and traction retinal detachment. Postoperative standard 6 mm 6-line OCT (Stratus OCTTM optical coherence tomography, Carl Zeiss Meditec, Inc., Dublin, CA) study centered on the macula and fundus photography were carried out between 7 months to 15 months after surgery. All cases were enrolled from the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan.
Data on patients' age, gender, systemic diseases, study eye, types and duration of diabetes mellitus, intraoperative diagnosis, and additional surgical procedures such as cryotherapy, scleral buckling [segmental sponge or 360º encircling buckle (Gore-Tex®, polytetrafluoroethylene, W. L. Gore \& Associates, Inc., Flagstaff, AZ)], or internal gas (C3F8 or SF6) are recorded. Further data about OCT findings, best-corrected visual acuity at the time of OCT images, and the duration of post-operative follow-up also are compiled. Different morphological appearances of the macula detected by OCT are categorized. These changes are compared between the two surgical subgroups. Correlations of the morphological changes with postoperative visual outcome are conducted.
For the purpose of OCT categorization, measured thickness of more than 300um in the central foveal area and more than 400um in the surrounding macular area in at least 3 examination lines with or without intraretinal cystic spaces or epiretinal membrane is defined as increase of macular thickness. Visible cystic spaces in and immediate adjacent to the fovea is categorized as foveal cysts. The presence of clear optical empty space between pigment epithelium and neurosensory retina are defined foveal detachment.
Statistical analysis In the first step of the statistical analyses, Chi-square test (or Fisher exact test, if n<5) and Kruskal-Wallis test, followed by the Mann-Whitney U test were used to analyze each variant individually for univariate analysis. In the second step, multivariate regression models were used for elucidating the independent influence of each morphological change on postoperative visual outcome. Levels of statistical significance were set at P<0.05.
- Conditions
- Proliferative Diabetic Retinopathy, Vitrectomy
- Keywords
- Diabetic vitrectomy, Epiretinal membrane (ERM), Macular appearance, Optical coherence tomography (OCT), Visual function
- Medical subject headings
- Epiretinal Membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular appearance
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 startMay 2005
- Primary completionJul 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies 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
- 108 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
- NCT00737022
- Sponsor's protocol ID
- 200805056R
- Status last verified
- Jul 2006
- 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 Appearance After Diabetic Vitrectomy for Fibrovascular Proliferation -An Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT00737022
- Acronym / sponsor ID
- 200805056R
- Conditions
- Proliferative Diabetic Retinopathy, Vitrectomy
- Keywords
- Diabetic vitrectomy, Epiretinal membrane (ERM), Macular appearance, Optical coherence tomography (OCT), Visual function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Dec 2006 (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.
Vitrectomy is one of the major treatment methods for complications of diabetic retinopathy. As surgical techniques and instruments improve, high anatomical success may be achieved; however, functional results are less favorable. Despite attached retina, postoperative visual function may be affected by various macular and disc abnormalities. Major changes include optic atrophy, atrophic retina, poor macular perfusion, and structural alternations of the macula. Funduscopy, fluorescein angiography, and, more recently, optical coherence tomography (OCT) can be used to detect and document these alterations. Although fluorescein angiography is valuable in the assessment of various macular lesions as well as retinal vascular abnormalities, its usefulness in evaluating macular changes is limited in eyes that have undergone diabetic vitrectomy. The quality of the images may be compromised by mild diffuse hyperfluorescence in the posterior pole in middle and late phase angiography, which obscures capillary detail and subtle macular changes. Furthermore, quantification of changes may not be possible. Recently, optical coherence tomography has become very useful for the detection of vitreomacular abnormalities. The examination is noninvasive, can qualify the changes and detect subtle abnormalities not evident with other imaging studies.
In this study, OCT was applied to investigate how common macular structure abnormalities are present after surgery for complications of diabetic retinopathy, and how they may affect visual prognosis.
Detailed description
From June 2008 to December 2008 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation were included in the study.
All cases have fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond equator in more than one quadrant. Complete removal of the visible posterior preretinal membrane was done during surgery in every case. All cases included in the study had attached retina postoperatively. Cases with rhegmatogenous detachment, silicone oil infusion, or post-operative moderate to dense cataract were not included. Surgical indications included progressive fibrovascular proliferation (FVP), and traction retinal detachment. Postoperative standard 6 mm 6-line OCT (Stratus OCTTM optical coherence tomography, Carl Zeiss Meditec, Inc., Dublin, CA) study centered on the macula and fundus photography were carried out between 7 months to 15 months after surgery. All cases were enrolled from the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan.
Data on patients' age, gender, systemic diseases, study eye, types and duration of diabetes mellitus, intraoperative diagnosis, and additional surgical procedures such as cryotherapy, scleral buckling [segmental sponge or 360º encircling buckle (Gore-Tex®, polytetrafluoroethylene, W. L. Gore \& Associates, Inc., Flagstaff, AZ)], or internal gas (C3F8 or SF6) are recorded. Further data about OCT findings, best-corrected visual acuity at the time of OCT images, and the duration of post-operative follow-up also are compiled. Different morphological appearances of the macula detected by OCT are categorized. These changes are compared between the two surgical subgroups. Correlations of the morphological changes with postoperative visual outcome are conducted.
For the purpose of OCT categorization, measured thickness of more than 300um in the central foveal area and more than 400um in the surrounding macular area in at least 3 examination lines with or without intraretinal cystic spaces or epiretinal membrane is defined as increase of macular thickness. Visible cystic spaces in and immediate adjacent to the fovea is categorized as foveal cysts. The presence of clear optical empty space between pigment epithelium and neurosensory retina are defined foveal detachment.
Statistical analysis In the first step of the statistical analyses, Chi-square test (or Fisher exact test, if n<5) and Kruskal-Wallis test, followed by the Mann-Whitney U test were used to analyze each variant individually for univariate analysis. In the second step, multivariate regression models were used for elucidating the independent influence of each morphological change on postoperative visual outcome. Levels of statistical significance were set at P<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Proliferative diabetic retinopathy
Key inclusion criteria (4 listed)
- From June 2008 to December 2008 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation are included in our study.
- All cases have fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond equator in more than one quadrant.
- Complete removal of the visible posterior preretinal membrane must be done during surgery in every case.
- All cases are included in the study have attached retina postoperatively.
Key exclusion criteria (3 listed)
- Cases with rhegmatogenous detachment, silicone oil infusion, or post-operative moderate to dense cataract are excluded.
- Patients are unable to follow-up regularly are not included.
- Patient refuses to join our study.
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
Macular appearance
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 Proliferative Diabetic Retinopathy and Vitrectomy, 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?
Macular appearance (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.