Diabetic RetinopathyNCT00001346
Diabetic Retinopathy and Visual Function Study
An observational study of Diabetic Retinopathy and Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy, Macular Degeneration, Vision, Subnormal
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1992to Oct 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients with diabetic retinopathy that has not been previously treated are eligible for the study.
Patients who have had laser photocoagulation (either focal or scatter) are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.
Read the detailed description
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.
- Keywords
- Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Photocoagulation, Psychophysical Testing, Stiles-Crawford Effect
- Medical subject headings
- Diabetic Retinopathy, Macular Degeneration, Vision, Low, Macular Edema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startNov 1992
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- 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
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001346
- Sponsor's protocol ID
- 930037
- Other IDs
- 93-EI-0037
- Status last verified
- Feb 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Higgins KE, Meyers SM, Jaffe MJ, Roy MS, de Monasterio FM. Temporary loss of foveal contrast sensitivity associated with panretinal photocoagulation. Arch Ophthalmol. 1986 Jul;104(7):997-1003. doi: 10.1001/archopht.1986.01050190055039.
PubMed 3729795Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1984 Apr;102(4):520-6. doi: 10.1001/archopht.1984.01040030398010.
PubMed 6367724Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
PubMed 6367725
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy and Visual Function Study
- ClinicalTrials.gov ID
- NCT00001346
- Acronym / sponsor ID
- 930037
- Keywords
- Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Photocoagulation, Psychophysical Testing, Stiles-Crawford Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Nov 1992
- Study completion
- Oct 2000
- First posted
- 10 Dec 2002 (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.
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.
Detailed description
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3729795Higgins KE, Meyers SM, Jaffe MJ, Roy MS, de Monasterio FM. Temporary loss of foveal contrast sensitivity associated with panretinal photocoagulation. Arch Ophthalmol. 1986 Jul;104(7):997-1003. doi: 10.1001/archopht.1986.01050190055039.
- Background: PubMed 6367724Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1984 Apr;102(4):520-6. doi: 10.1001/archopht.1984.01040030398010.
- Background: PubMed 6367725Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetic Retinopathy and Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001346, which also lists 3 linked publications.
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 4 Mar 2008.