Diabetic RetinopathyLIGHTNCT03242031
Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy
A study testing monospot panretinal photocoagulation and multispot panretinal photocoagulation in people with Diabetic Retinopathy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained… 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?
- monospot panretinal photocoagulation and multispot panretinal photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2017to 31 Aug 2022
- 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
- Persons who have provided written informed consent
- Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic criteria.
- Patients with severe non proliferative or early proliferative diabetic retinopathy
- Visual acuity of the treated eye >= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70 letters Early treatment Diabetic Retinopathy Study)
- Visual acuity of the contralateral eye >= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35 letters Early treatment Diabetic Retinopathy Study)
- Patients with a central macular thickness of 350 μm or less on Spectral Domain - Optical Coherence Tomography
- Patients with national health insurance cover
- Patients over 18 years old
Who cannot join
- Uncontrolled diabetes in the previous 6 months with intensive insulin therapy (glycated haemoglobin > 11).
- Uncontrolled hypertension.
- Florid diabetic retinopathy floride.
- Macular oedema due to causes other than diabetic retinopathy or in a context of vitreomacular traction.
- History of intravitreal treatment with anti-angiogenic agent or corticosteroids within the 12 previous months.
- History of treatment with laser in panretinal photocoagulation or focal laser on the treated eye.
Show all 13Show fewer
- History of eye surgery or laser capsulotomy within the previous 6 months
- History of renal failure requiring dialysis or kidney transplantation for diabetic nephropathy.
- Contra-indication for Tropicamide or Neo-synephrine
- History of uncontrolled glaucoma or hypertonia
- Patient with aphakia
- Adult under guardianship
- Pegnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Evaluation of Treatment with Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients with Severe Non-proliferative and Early Proliferative Diabetic Retinopathy
Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol.
Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.
- Conditions
- Diabetic Retinopathy
- Being tested
- monospot panretinal photocoagulation, multispot panretinal photocoagulation
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monospot panretinal photocoagulationProcedure or surgery
panretinal photocoagulation with monospot laser
multispot panretinal photocoagulationProcedure or surgery
panretinal photocoagulation with multispot laser
| Study group | Role | What they receive |
|---|---|---|
| 1 session | Experimental | Not described Receives: Procedure: multispot panretinal photocoagulation |
| 4 sessions | Active comparator | Not described Receives: Procedure: monospot panretinal photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost of treatment
Measured: 9 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start21 Jun 2017
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: The promoter decided to stop the study because the rate of enrolment was slowing down due to centres not adhering to the proposed arm.
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.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242031
- Sponsor's protocol ID
- CREUZOT PRME 2015
- Acronym
- LIGHT
- Status last verified
- Oct 2024
- First submitted
- 4 Aug 2017
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Treatment with Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients with Severe Non-proliferative and Early Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03242031
- Acronym / sponsor ID
- LIGHT / CREUZOT PRME 2015
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The promoter decided to stop the study because the rate of enrolment was slowing down due to centres not adhering to the proposed arm.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 8 Aug 2017 (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.
Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol.
Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 session | Experimental | Procedure: multispot panretinal photocoagulation |
| 4 sessions | Active comparator | Procedure: monospot panretinal photocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Persons who have provided written informed consent
- Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic criteria.
- Patients with severe non proliferative or early proliferative diabetic retinopathy
- Visual acuity of the treated eye >= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70 letters Early treatment Diabetic Retinopathy Study)
- Visual acuity of the contralateral eye >= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35 letters Early treatment Diabetic Retinopathy Study)
Key exclusion criteria (13 listed)
- Uncontrolled diabetes in the previous 6 months with intensive insulin therapy (glycated haemoglobin > 11).
- Uncontrolled hypertension.
- Florid diabetic retinopathy floride.
- Macular oedema due to causes other than diabetic retinopathy or in a context of vitreomacular traction.
- History of intravitreal treatment with anti-angiogenic agent or corticosteroids within the 12 previous months.
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 |
|---|---|---|
| monospot panretinal photocoagulationpanretinal photocoagulation with monospot laser | Procedure or surgery | 4 sessions |
| multispot panretinal photocoagulationpanretinal photocoagulation with multispot laser | Procedure or surgery | 1 session |
Primary outcome
cost of treatment
Time frame: 9 months after the start of treatment
Results and safety
The study was stopped early (reason given: The promoter decided to stop the study because the rate of enrolment was slowing down due to centres not adhering to the proposed arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monospot panretinal photocoagulation and multispot panretinal photocoagulation in people with Diabetic Retinopathy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Oct 2024. 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 France. 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 was stopped early (reason given: The promoter decided to stop the study because the rate of enrolment was slowing down due to centres not adhering to the proposed arm.). Results are not available in the source record.
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?
cost of treatment (time frame: 9 months after the start of treatment). 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 16 Oct 2024.