Proliferative Diabetic RetinopathyUMPDRNCT01044875
Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy
A study testing Pan retinal photocoagulation laser treatment in people with Proliferative Diabetic Retinopathy, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Pan retinal photocoagulation laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- Sep 2009to Oct 2011
- Phase
- Interventional
- 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
- Patient more than 18 year of age
- Eyes with proliferative diabetic retinopathy requiring laser PRP
- Newly diagnosed patient
- Patients with no other intervention/surgeries done before the study
Who cannot join
- Eyes with media opacity not allowing adequate laser photocoagulation
- Patients who have had previous laser photocoagulation
- Patients who have had previous vitreoretinal surgery
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Eye Research Centre
Kuala Lumpur, Kuala Lumpur, 50603
Kenneth C Fong, FRCOphth, +60379492060, fongcsk@um.edu.my
About this study
Official title: A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy
The purpose of this study is to measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome.
The study also compares pain score of patients receiving laser treatment and side effects of laser treatment.
Read the detailed description
Diabetes mellitus (DM) is a major medical problem throughout the world. The most common and potentially most blinding of these complications is proliferative diabetic retinopathy (PDR).
Panretinal photocoagulation is established as the gold standard of treatment, supported by the data of the Diabetic Retinopathy Study (DRS).This study found that laser treatment reduced the rate of severe visual loss by 50%. Currently the green 532nm laser is the most common wavelength used. However, this conventional green laser has some complications such as pain, vitreous haemorrhage, choroidal effusion and visual field loss.
Due to the complication of conventional lasers, the yellow laser (577 nm)with peak absorption of oxyhemoglobin and good absorption of melanin is postulated to be more effective at producing retinal laser burns with a lower power and less pain compared to the green laser.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Pan retinal photocoagulation laser treatment
- Keywords
- Diabetic retinopathy, Laser treatment, Complications, Laser wavelength
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan retinal photocoagulation laser treatmentProcedure or surgery
Also called Quantel Supra 577nm laser
Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.
| Study group | Role | What they receive |
|---|---|---|
| green laser 532 nm conventional | Active comparator | Current type of laser used for treatment of proliferative diabetic retinopathy Receives: Procedure: Pan retinal photocoagulation laser treatment |
| Yellow 577 nm laser | Active comparator | new laser wavelength for treatment of PDR Receives: Procedure: Pan retinal photocoagulation laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
Measured: 2 years
Secondary outcomes (1)
Patient pain score during laser procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth C Fong, FRCOphth, Principal investigator, University of Malaya Eye Research CentreNurliza Khaliddin, FRCS, Principal investigator, University of Malaya Eye Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044875
- Sponsor's protocol ID
- UMERC002
- Acronym
- UMPDR
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01044875
- Acronym / sponsor ID
- UMPDR / UMERC002
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Diabetic retinopathy, Laser treatment, Complications, Laser wavelength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 8 Jan 2010 (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 measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome.
The study also compares pain score of patients receiving laser treatment and side effects of laser treatment.
Detailed description
Diabetes mellitus (DM) is a major medical problem throughout the world. The most common and potentially most blinding of these complications is proliferative diabetic retinopathy (PDR).
Panretinal photocoagulation is established as the gold standard of treatment, supported by the data of the Diabetic Retinopathy Study (DRS).This study found that laser treatment reduced the rate of severe visual loss by 50%. Currently the green 532nm laser is the most common wavelength used. However, this conventional green laser has some complications such as pain, vitreous haemorrhage, choroidal effusion and visual field loss.
Due to the complication of conventional lasers, the yellow laser (577 nm)with peak absorption of oxyhemoglobin and good absorption of melanin is postulated to be more effective at producing retinal laser burns with a lower power and less pain compared to the green laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| green laser 532 nm conventional | Active comparator | Procedure: Pan retinal photocoagulation laser treatmentCurrent type of laser used for treatment of proliferative diabetic retinopathy |
| Yellow 577 nm laser | Active comparator | Procedure: Pan retinal photocoagulation laser treatmentnew laser wavelength for treatment of PDR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient more than 18 year of age
- Eyes with proliferative diabetic retinopathy requiring laser PRP
- Newly diagnosed patient
- Patients with no other intervention/surgeries done before the study
Key exclusion criteria (3 listed)
- Eyes with media opacity not allowing adequate laser photocoagulation
- Patients who have had previous laser photocoagulation
- Patients who have had previous vitreoretinal 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 |
|---|---|---|
| Pan retinal photocoagulation laser treatmentAlso: Quantel Supra 577nm laserEyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser. | Procedure or surgery | Yellow 577 nm laser, green laser 532 nm conventional |
Primary outcome
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
Time frame: 2 years
1 secondary outcome
Patient pain score during laser procedure
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
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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.
Kenneth C Fong, FRCOphth principal investigator
University of Malaya Eye Research Centre
Nurliza Khaliddin, FRCS principal investigator
University of Malaya Eye Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pan retinal photocoagulation laser treatment in people with Proliferative Diabetic Retinopathy, run by University of Malaya at 1 site in Malaysia.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Jan 2010. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thirupathy Annamalai, MBBS (+79492060, thirusukan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR) (time frame: 2 years). 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 8 Jan 2010.