Diabetic Macular EdemaNCT03641144
Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
A study testing Navigation laser and Traditional laser in people with Diabetic Macular Edema, run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Navigation laser and Traditional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Diagnosed as diabetic retinopathy with Mild macular edema
- BCVA≥0.5
- No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
Who cannot join
- Blood glucose was not controlled steadily(HbA1cd≥10%)
- Accompanied with severe hypertension（BP≥180/110mmHg）
- Taking part in other clinical trial within 3 months
- Planning panretinal photocoagulation(PRP) within 3 months
- Performed cataract surgery in the last 3 months
- Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
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- Accompanied with severe opacity of refractive media that maybe impact therapy and observation
- Accompanied with nystagmus
- Accompanied with some history that maybe interfere with result or increase the risk of patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yanjie Yan, +86-020-87332529, zocethics@163.com
Chenjin Jin, Ph.D, 13302209900, jinchj@mail.sysu.edu.cn
About this study
Official title: Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial
The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.
Read the detailed description
navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .
- Conditions
- Diabetic Macular Edema
- Being tested
- Navigation laser, Traditional laser
- Keywords
- Diabetic Macular Edema, navigation laser, laser photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation laserDevice
Also called Navigation laser photocoagulation treatment
Navigation laser device is a scanning slit-based instrument.before treatment the surgeon plan laser spots on the screen based on image(infrared, colour, fluorescein angiography)and then apply automated patterns and single spots as appropriate.the device will automatically carry out the plan.
Traditional laserDevice
Also called Traditional laser photocoagulation treatment
Traditional laser is a slitlamp based instrument.Surgeon operate traditional laer device while watching Participant's image(infrared, colour, fluorescein angiography) and then manually aim at and trigger laser.
| Study group | Role | What they receive |
|---|---|---|
| Navigation laser | Experimental | Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern Receives: Device: Navigation laser |
| Traditional laser | Active comparator | Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern Receives: Device: Traditional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Measured: 12 months
Secondary outcomes (5)
Central Retinal Thickness
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
Measured: 12 months
10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
Measured: 12 months
treatment time
treatment time is time from laser treatment beginning to end
Measured: 1 hour
Participants pain intensity
Participants pain intensity will be immediately measured by Visual Analogue Scale/Score （VAS）after treatment.The VAS is a straight horizontal line of fixed length（100 mm）. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (0) to the right (100).The patient marks on the line the point that participants feel represents their perception of their current pain intensity.the VAS score is determined by measuring the distance (mm) on the 100mm line between the "0" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) .
Measured: 1 hour
Number of laser spots within macular fovea
Number of laser spots within macular fovea will measured by foundus photograph
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Jun 2018
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- 80 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
- Chenjin Jin, Ph.D, Study chair, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641144
- Sponsor's protocol ID
- NLPD-ZOC
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial
- ClinicalTrials.gov ID
- NCT03641144
- Acronym / sponsor ID
- NLPD-ZOC
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, navigation laser, laser photocoagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Aug 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.
The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.
Detailed description
navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation laser | Experimental | Device: Navigation laserNavigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern |
| Traditional laser | Active comparator | Device: Traditional laserTraditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Diagnosed as diabetic retinopathy with Mild macular edema
- BCVA≥0.5
- No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
Key exclusion criteria (9 listed)
- Blood glucose was not controlled steadily(HbA1cd≥10%)
- Accompanied with severe hypertension（BP≥180/110mmHg）
- Taking part in other clinical trial within 3 months
- Planning panretinal photocoagulation(PRP) within 3 months
- Performed cataract surgery in the last 3 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 |
|---|---|---|
| Navigation laserAlso: Navigation laser photocoagulation treatmentNavigation laser device is a scanning slit-based instrument.before treatment the surgeon plan laser spots on the screen based on image(infrared, colour, fluorescein angiography)and then apply automated patterns and single spots as appropriate.the device will automatically carry out the plan. | Device | Navigation laser |
| Traditional laserAlso: Traditional laser photocoagulation treatmentTraditional laser is a slitlamp based instrument.Surgeon operate traditional laer device while watching Participant's image(infrared, colour, fluorescein angiography) and then manually aim at and trigger laser. | Device | Traditional laser |
Primary outcome
Best corrected visual acuity
Time frame: 12 months
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
5 secondary outcomes
Central Retinal Thickness
Time frame: 12 months
10°retinal sensitivity
Time frame: 12 months
treatment time
Time frame: 1 hour
Participants pain intensity
Time frame: 1 hour
Number of laser spots within macular fovea
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Chenjin Jin, Ph.D study chair
State Key Laboratory of Ophthalmology, 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 Navigation laser and Traditional laser in people with Diabetic Macular Edema, 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 4 inclusion and 9 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 21 Aug 2018. 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 Yajun Gong, Bachelor (15622253107, gongyaj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 12 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 21 Aug 2018.