Diabetic RetinopathyNCT02816073
Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy
A study testing Pan-retinal photocoagulation using pattern scanning laser in people with Diabetic Retinopathy and Lasers, run by United Christian Hospital.
Trial summary
A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Lasers, Treatment Outcome
- What is being tested?
- Pan-retinal photocoagulation using pattern scanning laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Apr 2016
- 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
- All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November
Who cannot join
- significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
- any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
- those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
- clinically significant macular oedema on clinical examination.
About this study
Official title: Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study
A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots
- Conditions
- Diabetic Retinopathy, Lasers, Treatment Outcome
- Being tested
- Pan-retinal photocoagulation using pattern scanning 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.
Pan-retinal photocoagulation using pattern scanning laserDevice
Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session
| Study group | Role | What they receive |
|---|---|---|
| 1,700 | Active comparator | Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser Receives: Device: Pan-retinal photocoagulation using pattern scanning laser |
| 2,500 | Active comparator | Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser Receives: Device: Pan-retinal photocoagulation using pattern scanning laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of neovascularization
Fluorescein angiogram assessment by independent observer
Measured: 3 months
Secondary outcomes (5)
Activity of neovascularization
Descriptive analysis of fundus fluorescein angiogram by independent observer into 4 categories: no leakage, reduced leakage, same leakage, increased leakage
Measured: 3 months
Best corrected visual acuity
Measured: 1 week, 1 month, 3 months, 6 months
Complications
choroidal detachment, exudative retinal detachment, retinal breaks
Measured: 1 week, 1 month, 3 months, 6 months
Central foveal thickness
Measured by spectral domain optical coherence tomography (Heidelberg Spectralis)
Measured: 1 week
Retreatment rate
Patients requiring retreatment with pan-retinal photocoagulation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionApr 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Chung-yee Chung, United Christian Hospital
- Investigators
- Kenneth KW Li, MBChB, Principal investigator, United Christian Hospital; The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816073
- Sponsor's protocol ID
- 12-0079
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study
- ClinicalTrials.gov ID
- NCT02816073
- Acronym / sponsor ID
- 12-0079
- Conditions
- Diabetic Retinopathy, Lasers, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Jun 2016 (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.
A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1,700 | Active comparator | Device: Pan-retinal photocoagulation using pattern scanning laserPatients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser |
| 2,500 | Active comparator | Device: Pan-retinal photocoagulation using pattern scanning laserPatients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November
Key exclusion criteria (4 listed)
- significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
- any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
- those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
- clinically significant macular oedema on clinical examination.
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 using pattern scanning laserPatients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session | Device | 1,700, 2,500 |
Primary outcome
Regression of neovascularization
Time frame: 3 months
Fluorescein angiogram assessment by independent observer
5 secondary outcomes
Activity of neovascularization
Time frame: 3 months
Best corrected visual acuity
Time frame: 1 week, 1 month, 3 months, 6 months
Complications
Time frame: 1 week, 1 month, 3 months, 6 months
Central foveal thickness
Time frame: 1 week
Retreatment rate
Time frame: 6 months
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 29 Jun 2016.
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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 KW Li, MBChB principal investigator
United Christian Hospital; The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Pan-retinal photocoagulation using pattern scanning laser in people with Diabetic Retinopathy and Lasers, run by United Christian Hospital.
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 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 29 Jun 2016. 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?
Regression of neovascularization (time frame: 3 months). 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 29 Jun 2016.