Diabetic Macular EdemaMMGNCT02555956
Grid Laser for Diffuse Diabetic Maculopathy
An observational study of Diabetic Macular Edema, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2012to Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients having diffuse diabetic macular edema.
Who may be able to join
- Diabetic patients with macular edema.
- both sexes
- conset to participate.
Who cannot join
- focal edema.
- patients requiring only the focal laser.
- patients with proferative diabetic retinopathy.
- Patients with ischaemic maculopathy on fundus fluorescein angiography.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dow universty Hospital,Dow international Medical college
Karachi, Sindh, 75500
About this study
Official title: Subthreshold Double Frequency Nd. YAG Grid Laser for Diffuse Diabetic Maculopathy
Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Keywords
- Macular grid, Subthreshold, diabetic macular edema, decrease in visual acuity
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of visual acuity after grid laser
Visual acuity will be mesured pre laser and 06 weeks post laser
Measured: 6 week
Secondary outcomes (1)
Complication
Patiens willbe asked and examined for any potentiail anticipated complication.
Measured: during first six weeks after laser
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamshed Ahmed, Dow University of Health Sciences
- Investigators
- Dr. Jamshed Ahmed, FCPS, Principal investigator, Dow university of health sciences, karachiJamshed Ahmed, FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555956
- Sponsor's protocol ID
- Macular Grid Laser
- Acronym
- MMG
- Status last verified
- Sep 2015
- First submitted
- 6 Aug 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Double Frequency Nd. YAG Grid Laser for Diffuse Diabetic Maculopathy
- ClinicalTrials.gov ID
- NCT02555956
- Acronym / sponsor ID
- MMG / Macular Grid Laser
- Conditions
- Diabetic Macular Edema
- Keywords
- Macular grid, Subthreshold, diabetic macular edema, decrease in visual acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Sep 2015 (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.
Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients having diffuse diabetic macular edema.
Key inclusion criteria (3 listed)
- Diabetic patients with macular edema.
- both sexes
- conset to participate.
Key exclusion criteria (4 listed)
- focal edema.
- patients requiring only the focal laser.
- patients with proferative diabetic retinopathy.
- Patients with ischaemic maculopathy on fundus fluorescein angiography.
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
Improvement of visual acuity after grid laser
Time frame: 6 week
Visual acuity will be mesured pre laser and 06 weeks post laser
1 secondary outcome
Complication
Time frame: during first six weeks after laser
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 22 Sep 2015.
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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.
Dr. Jamshed Ahmed, FCPS principal investigator
Dow university of health sciences, karachi
Jamshed Ahmed, FCPS principal investigator
Dow University of Health Sciences
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 Macular Edema, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 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 22 Sep 2015. 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 Pakistan. 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?
Improvement of visual acuity after grid laser (time frame: 6 week). 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 22 Sep 2015.