Diabetic RetinopathyPhase 3NCT00355680
Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy
A Phase 3 study testing Green Laser (Aurolas, Aurolab) and Green Laser (Iridex) in people with Diabetic Retinopathy, run by Aurolab at 1 site in India.
Trial summary
To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Green Laser (Aurolas, Aurolab) and Green Laser (Iridex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2005to Jul 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 18 years of age
- Eyes with proliferative diabetic retinopathy requiring laser photocoagulation
Who cannot join
- Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
- Patients requiring more than two sessions of laser photocoagulation
- Patients who had undergone previous laser photocoagulation
- Patients who had undergone any previous vitreo-retinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy
To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.
Read the detailed description
Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.
In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.
- Conditions
- Diabetic Retinopathy
- Being tested
- Green Laser (Aurolas, Aurolab), Green Laser (Iridex)
- Keywords
- Retina, Retinal Diseases, Retinal Vessels, Laser Coagulation
- Medical subject headings
- Diabetic Retinopathy, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Laser (Aurolas, Aurolab)Device
Also called Aurolas
Green laser developed by Aurolab
Green Laser (Iridex)Device
Also called Iridex
Already available green laser
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aurolab Green Laser Receives: Device: Green Laser (Aurolas, Aurolab) |
| 2 | Active comparator | Available Green Laser Receives: Device: Green Laser (Iridex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation of burn
Measured: 2 months, 4 months, 6 months post laser
Lateral spread of burn
Measured: 2 months, 4 months, 6 months post laser
Regression of new vessels
Measured: 2 months, 4 months, 6 months post laser
Secondary outcomes (4)
Choroidal detachment
Measured: 2 months, 4 months, 6 months post laser
Retinal detachment
Measured: 2 months, 4 months, 6 months post laser
Tractional retinal detachment
Measured: 2 months, 4 months, 6 months post laser
Bruch's membrane rupture
Measured: 2 months, 4 months, 6 months post laser
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startDec 2005
- Primary completionJul 2006
- Study completionJul 2006
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Collaborators
- Raja Ramanna Centre for Advanced Technology (RRCAT)
- Investigators
- Chandra Mohan, MS, Principal investigator, Arvind Eye Hospital, MaduraiDhananjay Shukla, MS, Principal investigator, Aravind Eye HospitalNaresh Babu, MS, FNB, Principal investigator, Aravind Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355680
- Sponsor's protocol ID
- 2PR1210511
- Status last verified
- Feb 2009
- First submitted
- 21 Jul 2006
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00355680
- Acronym / sponsor ID
- 2PR1210511
- Conditions
- Diabetic Retinopathy
- Keywords
- Retina, Retinal Diseases, Retinal Vessels, Laser Coagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Collaborators
- Raja Ramanna Centre for Advanced Technology (RRCAT)
- Study start
- Dec 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 24 Jul 2006 (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.
To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.
Detailed description
Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.
In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Green Laser (Aurolas, Aurolab)Aurolab Green Laser |
| 2 | Active comparator | Device: Green Laser (Iridex)Available Green Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients more than 18 years of age
- Eyes with proliferative diabetic retinopathy requiring laser photocoagulation
Key exclusion criteria (4 listed)
- Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
- Patients requiring more than two sessions of laser photocoagulation
- Patients who had undergone previous laser photocoagulation
- Patients who had undergone any previous vitreo-retinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Laser (Aurolas, Aurolab)Also: AurolasGreen laser developed by Aurolab | Device | 1 |
| Green Laser (Iridex)Also: IridexAlready available green laser | Device | 2 |
Primary outcome
Pigmentation of burn
Time frame: 2 months, 4 months, 6 months post laser
Lateral spread of burn
Time frame: 2 months, 4 months, 6 months post laser
Regression of new vessels
Time frame: 2 months, 4 months, 6 months post laser
4 secondary outcomes
Choroidal detachment
Time frame: 2 months, 4 months, 6 months post laser
Retinal detachment
Time frame: 2 months, 4 months, 6 months post laser
Tractional retinal detachment
Time frame: 2 months, 4 months, 6 months post laser
Bruch's membrane rupture
Time frame: 2 months, 4 months, 6 months post 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 11 Feb 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.
Chandra Mohan, MS principal investigator
Arvind Eye Hospital, Madurai
Dhananjay Shukla, MS principal investigator
Aravind Eye Hospital
Naresh Babu, MS, FNB principal investigator
Aravind Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Green Laser (Aurolas, Aurolab) and Green Laser (Iridex) in people with Diabetic Retinopathy, run by Aurolab at 1 site in India.
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 2 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 11 Feb 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pigmentation of burn (time frame: 2 months, 4 months, 6 months post laser). 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 11 Feb 2009.