Severe Non-proliferative Diabetic RetinopathyS-PRPNCT01759121
Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR
A study testing T-PRP and S-PRP in people with Severe Non-proliferative Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Severe Non-proliferative Diabetic Retinopathy
- What is being tested?
- T-PRP and S-PRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2018
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe non-proliferative diabetic retinopathy
- Age:45-80 years
- Best corrected visual acuity(BCVA) ≥20/100,Myopia≤-6 degree(-6D)
- No photocoagulation (PRP) before this clinical trial and no major ocular surgery (including cataract extraction, or any other intraocular surgery) within 3 months
- Ability and willingness to provide informed consent
Who cannot join
- Participate in other clinical trials within 3 months
- Severe refractive media turbidity; Unable to accept laser treatment such as nystagmus, etc
- Medically or mentally unstable(including cardiovascular disorders, cerebrovascular diseases,liver and kidney disease,hematological disorder and psychosis
- Conditions that in the opinion of the investigator would interfere trial results or increase risk
- Conditions that in the opinion of the investigator would preclude participation in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Peipei Wu, 13602457876, ree04@126.com
Chen-jin Jin
About this study
Official title: Randomized, Parallel Controlled, Clinical-trial on 532nm Laser Partially Subthreshold Panretinal Photocoagulation With PASCAL Endpoint Management Function for Severe Non-proliferative Diabetic Retinopathy(NPDR)
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy.
Read the detailed description
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy : (1)To evaluate therapeutic effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy; (2)To compare side effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function on retina with traditional visible endpoint panretinal photocoagulation.
- Being tested
- T-PRP, S-PRP
- Keywords
- severe non-proliferative diabetic retinopathy, subthreshold, panretinal photocoagulation, PASCAL, endpoint management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PRPRadiation
Also called Traditional-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
S-PRPRadiation
Also called Subthreshold PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
| Study group | Role | What they receive |
|---|---|---|
| T-PRP | Active comparator | 532nm-short pulse panretinal photocoagulation with PASCAL function Receives: Radiation: T-PRP |
| S-PRP | Experimental | 532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function Receives: Radiation: S-PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of best corrected visual acuity
best corrected visual acuity
Measured: 1 year
the probability of vitreous haemorrhage
Measured: 1 year
Secondary outcomes (8)
Central Retinal Thickness
Measured: 1 year
foveal volume of macula
Measured: 1 year
amount of microaneurysms
Measured: 1 year
amount of bard exudate
Measured: 1 year
amount of retinal hemorrhage
Measured: 1 year
amount and area of IRMA
Measured: 1 year
amount of neovascularization
Measured: 1 year
change of ischemia area
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Non-proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chen-jin Jin, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPei-pei Wu, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759121
- Sponsor's protocol ID
- S-PASCAL-PRP
- Other IDs
- ChiCTR-TRC-12002735
- Acronym
- S-PRP
- Status last verified
- Oct 2017
- First submitted
- 18 Dec 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Z, Lu T, Zhou L, Huang C, Zhao H, Liang J, Li C, Cong Q, Lan Y, Jin C. Retinal and Choroidal Alterations in Diabetic Retinopathy Treatment using Subthreshold Panretinal Photocoagulation with Endpoint Management Algorithm: A Secondary Analysis of a Randomized Clinical Trial. Ophthalmol Ther. 2023 Aug;12(4):1867-1880. doi: 10.1007/s40123-023-00713-0. Epub 2023 Apr 30.
PubMed 37120774Zhao H, Zhou L, Lai K, Yu M, Huang C, Xu F, Li C, Lu L, Jin C. Comparison of functional changes of retina after subthreshold and threshold pan-retinal photocoagulation in severe non-proliferative diabetic retinopathy. Lasers Med Sci. 2022 Dec;37(9):3561-3569. doi: 10.1007/s10103-022-03635-8. Epub 2022 Sep 7.
PubMed 36070046
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel Controlled, Clinical-trial on 532nm Laser Partially Subthreshold Panretinal Photocoagulation With PASCAL Endpoint Management Function for Severe Non-proliferative Diabetic Retinopathy(NPDR)
- ClinicalTrials.gov ID
- NCT01759121
- Acronym / sponsor ID
- S-PRP / S-PASCAL-PRP
- Keywords
- severe non-proliferative diabetic retinopathy, subthreshold, panretinal photocoagulation, PASCAL, endpoint management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Jan 2013 (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.
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy.
Detailed description
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy : (1)To evaluate therapeutic effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy; (2)To compare side effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function on retina with traditional visible endpoint panretinal photocoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-PRP | Active comparator | Radiation: T-PRP532nm-short pulse panretinal photocoagulation with PASCAL function |
| S-PRP | Experimental | Radiation: S-PRP532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of severe non-proliferative diabetic retinopathy
- Age:45-80 years
- Best corrected visual acuity(BCVA) ≥20/100,Myopia≤-6 degree(-6D)
- No photocoagulation (PRP) before this clinical trial and no major ocular surgery (including cataract extraction, or any other intraocular surgery) within 3 months
- Ability and willingness to provide informed consent
Key exclusion criteria (5 listed)
- Participate in other clinical trials within 3 months
- Severe refractive media turbidity; Unable to accept laser treatment such as nystagmus, etc
- Medically or mentally unstable(including cardiovascular disorders, cerebrovascular diseases,liver and kidney disease,hematological disorder and psychosis
- Conditions that in the opinion of the investigator would interfere trial results or increase risk
- Conditions that in the opinion of the investigator would preclude participation in the study
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 |
|---|---|---|
| T-PRPAlso: Traditional-PRP532nm-short pulse panretinal photocoagulation with PASCAL function | Radiation | T-PRP |
| S-PRPAlso: Subthreshold PRP532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function | Radiation | S-PRP |
Primary outcome
change of best corrected visual acuity
Time frame: 1 year
best corrected visual acuity
the probability of vitreous haemorrhage
Time frame: 1 year
8 secondary outcomes
Central Retinal Thickness
Time frame: 1 year
foveal volume of macula
Time frame: 1 year
amount of microaneurysms
Time frame: 1 year
amount of bard exudate
Time frame: 1 year
amount of retinal hemorrhage
Time frame: 1 year
amount and area of IRMA
Time frame: 1 year
amount of neovascularization
Time frame: 1 year
change of ischemia area
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 37120774Li Z, Lu T, Zhou L, Huang C, Zhao H, Liang J, Li C, Cong Q, Lan Y, Jin C. Retinal and Choroidal Alterations in Diabetic Retinopathy Treatment using Subthreshold Panretinal Photocoagulation with Endpoint Management Algorithm: A Secondary Analysis of a Randomized Clinical Trial. Ophthalmol Ther. 2023 Aug;12(4):1867-1880. doi: 10.1007/s40123-023-00713-0. Epub 2023 Apr 30.
- Derived from this study: PubMed 36070046Zhao H, Zhou L, Lai K, Yu M, Huang C, Xu F, Li C, Lu L, Jin C. Comparison of functional changes of retina after subthreshold and threshold pan-retinal photocoagulation in severe non-proliferative diabetic retinopathy. Lasers Med Sci. 2022 Dec;37(9):3561-3569. doi: 10.1007/s10103-022-03635-8. Epub 2022 Sep 7.
- a clinical study on subthreshold panretinal photocoagulation for proliferative diabetic retinopathy (PDR)Link provided by the sponsor.
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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.
Chen-jin Jin study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Pei-pei Wu principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-PRP and S-PRP in people with Severe Non-proliferative Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 5 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 13 Oct 2017. 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 China. 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 Pei-pei Wu (13602457876, ree04@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of best corrected visual acuity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01759121, which also lists 2 linked publications.
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 13 Oct 2017.