Diabetic RetinopathyNCT03571659
Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema
An observational study of Diabetic Retinopathy, run by L.V. Prasad Eye Institute.
Trial summary
To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Laser
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2014to 11 Aug 2015
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asian
Who may be able to join
- Eyes with DME (center or non-center involving) with <350 microns central retinal thickness
Who cannot join
- Subfoveal exudates, history of VR surgery, history of macular laser
About this study
Official title: To Assess the Safety and Efficacy of Two Subthreshold Parameters (5% and 15% Duty Cycle (DC)) Compared to Standard ETDRS (Early Treatment of Diabetic Retinopathy Study) Continuous Wave (CW) Laser
To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser
Read the detailed description
Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group.
Focal to Mas+ confluent burns to areas of diffuse leakage
- Conditions
- Diabetic Retinopathy
- Being tested
- Laser
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| two subthreshold parameters | 5% and 15% duty cycle (DC) Receives: Procedure: Laser | |
| standard ETDRS | early treatment of diabetic retinopathy study Receives: Procedure: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA
Comparing the number of leaking microaneuyrms baseline to 6 weeks with 3 types of lasers (two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS continuous wave (CW) laser.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start22 Dec 2014
- Primary completion22 Dec 2014
- Study completion11 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.V. Prasad Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jay Chhablani, L.V. Prasad Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571659
- Sponsor's protocol ID
- LVPEI-2018
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chhablani J, Alshareef R, Kim DT, Narayanan R, Goud A, Mathai A. Comparison of different settings for yellow subthreshold laser treatment in diabetic macular edema. BMC Ophthalmol. 2018 Jul 11;18(1):168. doi: 10.1186/s12886-018-0841-z.
PubMed 29996798
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Safety and Efficacy of Two Subthreshold Parameters (5% and 15% Duty Cycle (DC)) Compared to Standard ETDRS (Early Treatment of Diabetic Retinopathy Study) Continuous Wave (CW) Laser
- ClinicalTrials.gov ID
- NCT03571659
- Acronym / sponsor ID
- LVPEI-2018
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- L.V. Prasad Eye InstituteUniversity, hospital or other
- Study start
- 22 Dec 2014 (actual)
- Primary completion
- 22 Dec 2014 (actual)
- Study completion
- 11 Aug 2015 (actual)
- First posted
- 27 Jun 2018 (actual)
- 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 assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser
Detailed description
Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group.
Focal to Mas+ confluent burns to areas of diffuse leakage
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two subthreshold parameters | – | Procedure: Laser5% and 15% duty cycle (DC) |
| standard ETDRS | – | Procedure: Laserearly treatment of diabetic retinopathy study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian
Key inclusion criteria (1 listed)
- Eyes with DME (center or non-center involving) with <350 microns central retinal thickness
Key exclusion criteria (1 listed)
- Subfoveal exudates, history of VR surgery, history of macular laser
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 |
|---|---|---|
| Laser | Procedure or surgery | standard ETDRS, two subthreshold parameters |
Primary outcome
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA
Time frame: 3 months
Comparing the number of leaking microaneuyrms baseline to 6 weeks with 3 types of lasers (two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS continuous wave (CW) 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 27 Jun 2018.
- Derived from this study: PubMed 29996798Chhablani J, Alshareef R, Kim DT, Narayanan R, Goud A, Mathai A. Comparison of different settings for yellow subthreshold laser treatment in diabetic macular edema. BMC Ophthalmol. 2018 Jul 11;18(1):168. doi: 10.1186/s12886-018-0841-z.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by L.V. Prasad Eye Institute.
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 1 inclusion and 1 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03571659, which also lists 1 linked publication.
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 27 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.