Diabetic RetinopathyNCT00906659
Visual Function, Center Point Thickness and Macular Volume After Photocoagulation
An observational study of Diabetic Retinopathy and Macular Edema, run by Hospital Juarez de Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- How many people
- 89 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2006to Mar 2008
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target population were type 2 diabetics from Mexico City and its metropolitan area, accessible population were the patients who attended a General Hospital in Mexico City
Who may be able to join
- type 2 diabetes
- regardless of diabetes duration and retinopathy severity level
- one or both eyes with focal clinically significant macular edema
- treated with selective or focal photocoagulation
- visual capacity under subjective refraction before and three weeks after treatment
- adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it
Who cannot join
- patients with myopia over -6.00 diopters
- any retinal disease different from diabetic retinopathy at the moment of photocoagulation
- eyes with a thickened posterior vitreous
- eyes with vitreoretinal traction at the macula
- if they had required scatter photocoagulation before the three weeks evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema
The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.
Read the detailed description
Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. Differences in research can achieve statistical significance, without clinical significance. A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.
- Conditions
- Diabetic Retinopathy, Macular Edema
- Keywords
- center point thickness, diabetic retinopathy, diabetic macular edema, macular volume, visual capacity, visual function
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetic macular edema | type 2 patients who had been treated with selective photocoagulation for clinically significant macular edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual capacity (under subjective refractive correction was measured in decimal equivalent)
Measured: before the treatment and 3 weeks after photocoagulation
center point thickness (measured in µm)
Measured: before the treatment and 3 weeks after photocoagulation
macular volume (measured in mm3)
Measured: before the treatment and 3 weeks after photocoagulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Investigators
- Dulce M Razo Blanco Hernandez, MD, Study director, Hospital Juarez de MexicoVirgilio Lima Gomez, MD, MSc, Study chair, Hospital Juarez de MexicoAleyda S Cruz Diaz, MD, Principal investigator, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906659
- Sponsor's protocol ID
- HJM 1453/08.02.26
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00906659
- Acronym / sponsor ID
- HJM 1453/08.02.26
- Conditions
- Diabetic Retinopathy, Macular Edema
- Keywords
- center point thickness, diabetic retinopathy, diabetic macular edema, macular volume, visual capacity, visual function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 May 2009 (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 correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.
Detailed description
Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. Differences in research can achieve statistical significance, without clinical significance. A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic macular edema | – | –type 2 patients who had been treated with selective photocoagulation for clinically significant macular edema |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population were type 2 diabetics from Mexico City and its metropolitan area, accessible population were the patients who attended a General Hospital in Mexico City
Key inclusion criteria (6 listed)
- type 2 diabetes
- regardless of diabetes duration and retinopathy severity level
- one or both eyes with focal clinically significant macular edema
- treated with selective or focal photocoagulation
- visual capacity under subjective refraction before and three weeks after treatment
Key exclusion criteria (5 listed)
- patients with myopia over -6.00 diopters
- any retinal disease different from diabetic retinopathy at the moment of photocoagulation
- eyes with a thickened posterior vitreous
- eyes with vitreoretinal traction at the macula
- if they had required scatter photocoagulation before the three weeks evaluation
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
visual capacity (under subjective refractive correction was measured in decimal equivalent)
Time frame: before the treatment and 3 weeks after photocoagulation
center point thickness (measured in µm)
Time frame: before the treatment and 3 weeks after photocoagulation
macular volume (measured in mm3)
Time frame: before the treatment and 3 weeks after photocoagulation
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 21 May 2009.
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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.
Dulce M Razo Blanco Hernandez, MD study director
Hospital Juarez de Mexico
Virgilio Lima Gomez, MD, MSc study chair
Hospital Juarez de Mexico
Aleyda S Cruz Diaz, MD principal investigator
Hospital Juarez de Mexico
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 Edema, run by Hospital Juarez de Mexico at 1 site in Mexico.
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 6 inclusion and 5 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 21 May 2009. 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 Mexico. 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?
visual capacity (under subjective refractive correction was measured in decimal equivalent) (time frame: before the treatment and 3 weeks after photocoagulation). The study lists 3 primary outcomes in all. 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 21 May 2009.