Back to resultsNavigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Navigation laser
Traditional laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, navigation laser, laser photocoagulation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Navigation laser
Traditional laser
Arm Description
Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Outcomes
Primary Outcome Measures
Best corrected visual acuity
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Secondary Outcome Measures
Central Retinal Thickness
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
treatment time
treatment time is time from laser treatment beginning to end
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) .
Number of laser spots within macular fovea
Number of laser spots within macular fovea will measured by foundus photograph
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03641144
Brief Title
Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
Official Title
Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, navigation laser, laser photocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Navigation laser
Arm Type
Experimental
Arm Description
Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Arm Title
Traditional laser
Arm Type
Active Comparator
Arm Description
Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Intervention Type
Device
Intervention Name(s)
Navigation laser
Other Intervention Name(s)
Navigation laser photocoagulation treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional laser
Other Intervention Name(s)
Traditional laser photocoagulation treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central Retinal Thickness
Description
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
Time Frame
12 months
Title
10°retinal sensitivity
Description
Retinal sensitivity will be measured by microperimetry
Time Frame
12 months
Title
treatment time
Description
treatment time is time from laser treatment beginning to end
Time Frame
1 hour
Title
Participants pain intensity
Description
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) .
Time Frame
1 hour
Title
Number of laser spots within macular fovea
Description
Number of laser spots within macular fovea will measured by foundus photograph
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yajun Gong, Bachelor
Phone
15622253107
Email
gongyaj@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chenjin Jin, Ph.D
Phone
13302209900
Email
jinchj@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, Ph.D
Organizational Affiliation
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanjie Yan
Phone
+86-020-87332529
Email
zocethics@163.com
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, Ph.D
Phone
13302209900
Email
jinchj@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
We'll reach out to this number within 24 hrs