DIABETES MELLITUSNCT02217306
Contrast Sensitivity and Diabetic Macular Edema
An observational study of DIABETES MELLITUS and DIABETIC RETINOPATHY, run by Hospital Juarez de Mexico at 1 site in Mexico.
Trial summary
Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- DIABETES MELLITUS, DIABETIC RETINOPATHY, MACULAR EDEMA
- How many people
- 132 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2014to Aug 2014
- 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: Diabetic patients attended at Ophthalmology service in a general hospital
Who may be able to join
- DIABETIC PATIENTS
- 40-60 YEARS OLD
- ANY GENDER
- VISUAL ACUITY >0.25 IN DECIMAL EQUIVALENT,
Who cannot join
- PATIENTS WITH CATARACTS OR OTHER MACULOPATHY
- PATIENTS WITH CONTACT LENSES
- PATIENTS WITH REFRACTIVE ERROR >6.00DP
- PATIENTS WITH PREVIOUS OCULAR SURGERY
Trial locations and contacts
1 site in 1 country.
About this study
Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and in patients with diabetic macular edema so if it is a difference, research for therapeutic strategies to improve it in this patients.
Read the detailed description
Contrast sensitivity is defined as a subjective measurement, it is the ability to separate the image between figure and background, taking into account the minimum amount of light required; it is evaluated by the contrast threshold, which is the smallest amount of contrast needed to be able to see a target and solve their characteristics, would be his reciprocal value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where > 51 years have decreased compared to contrast sensitivity studies international; further that contrast sensitivity in older groups of 41 years is decreased high frequency.
- Conditions
- DIABETES MELLITUS, DIABETIC RETINOPATHY, MACULAR EDEMA
- Medical subject headings
- Diabetes Mellitus, 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 |
|---|---|---|
| Contrast Sensitivity | Determine changes in contrast sensitivity frequences and visual function (visual acuity) after one month of treatment photocoagulation in macular edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity
Diabetic patients who are attended at Ophthalmology service in a general hospital undergo to contrast sensitivity test evaluating all frequency by software with 5 spacial frequency (1.5, 3, 6, 12 and 18 cycle grade, Stereoptical Co 1996) in the Visual Basic program.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIABETES MELLITUSStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dulce Milagros Razo Blanco Hernández, Hospital Juarez de Mexico
- Investigators
- DULCE MI RAZO BLANCO HERNANDEZ, MD, Principal investigator, Hospital Juarez de MexicoSURISADAI SERAFIN SOLIS, MSc, Study chair, INSTITUTO POLITECNICO NACIONALLOURDES CA ORTEGA LUNA, MSc, Study chair, INSTITUTO POLITECNICO NACIONALVIRGILIO LIMA GOMEZ, MD, MSc, Study director, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217306
- Sponsor's protocol ID
- HJM2295/14R
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Sensitivity and Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02217306
- Acronym / sponsor ID
- HJM2295/14R
- Conditions
- DIABETES MELLITUS, DIABETIC RETINOPATHY, MACULAR EDEMA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Aug 2014 (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.
Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and in patients with diabetic macular edema so if it is a difference, research for therapeutic strategies to improve it in this patients.
Detailed description
Contrast sensitivity is defined as a subjective measurement, it is the ability to separate the image between figure and background, taking into account the minimum amount of light required; it is evaluated by the contrast threshold, which is the smallest amount of contrast needed to be able to see a target and solve their characteristics, would be his reciprocal value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where > 51 years have decreased compared to contrast sensitivity studies international; further that contrast sensitivity in older groups of 41 years is decreased high frequency.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast Sensitivity | – | –Determine changes in contrast sensitivity frequences and visual function (visual acuity) after one month of treatment photocoagulation in macular edema |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients attended at Ophthalmology service in a general hospital
Key inclusion criteria (4 listed)
- DIABETIC PATIENTS
- 40-60 YEARS OLD
- ANY GENDER
- VISUAL ACUITY >0.25 IN DECIMAL EQUIVALENT,
Key exclusion criteria (4 listed)
- PATIENTS WITH CATARACTS OR OTHER MACULOPATHY
- PATIENTS WITH CONTACT LENSES
- PATIENTS WITH REFRACTIVE ERROR >6.00DP
- PATIENTS WITH PREVIOUS OCULAR SURGERY
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
Contrast Sensitivity
Time frame: up to 8 months
Diabetic patients who are attended at Ophthalmology service in a general hospital undergo to contrast sensitivity test evaluating all frequency by software with 5 spacial frequency (1.5, 3, 6, 12 and 18 cycle grade, Stereoptical Co 1996) in the Visual Basic program.
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 15 Aug 2014.
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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 MI RAZO BLANCO HERNANDEZ, MD principal investigator
Hospital Juarez de Mexico
SURISADAI SERAFIN SOLIS, MSc study chair
INSTITUTO POLITECNICO NACIONAL
LOURDES CA ORTEGA LUNA, MSc study chair
INSTITUTO POLITECNICO NACIONAL
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 DIABETES MELLITUS and DIABETIC RETINOPATHY, 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 4 inclusion and 4 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 15 Aug 2014. 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?
Contrast Sensitivity (time frame: up to 8 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 15 Aug 2014.