Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Primary Purpose
Diabetic Retinopathy, Macula Edema
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Yellow micro-pulse laser
Diode micro-pulse laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring micro-pulse laser, trans-foveal
Eligibility Criteria
Inclusion Criteria:
- bilateral diabetic macular edema
- center involving confirmed by Optical coherence tomogram (OCT)
Exclusion Criteria:
- any non-diabetic macular edema
- significant media opacities
- previous laser treatment, any intraocular surgery within the past 6 months
- previous intravitreal injections of any drug within the past 6 months
Sites / Locations
- Faculty of Medicine, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Yellow MPL
Diode MPL
Arm Description
Outcomes
Primary Outcome Measures
Change in Central Retinal Thickness (CRT)
detecting changes in the thickness of the center of the macula
Change in the Best Corrected Visual Acuity (BCVA)
detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04359771
Brief Title
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Official Title
Yellow Micropulse Laser 577-nm vs Infrared Diode Micropulse Laser 810-nm for the Treatment of Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.
Detailed Description
This was a prospective randomized comparative study that included 30 eyes of 15 patients with bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital, Cairo University. The study's protocol was reviewed and approved by board of the ophthalmology department, Cairo University, and was in concordance with the tents of Declaration of Helsinki. Eligible patients were informed about the study's objectives, methodology, risks and benefits. A written informed consent was obtained from every patient included in this study.Preliminary examination was in the form of slit-lamp examination, fundus examination, intra ocular pressure measurement, and best corrected visual acuity (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to all patients before treatment to measure the central retinal thickness (CRT). The eyes were randomized into two groups; one eye (right eye) of each patient was treated with 577-nm yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL. Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macula Edema
Keywords
micro-pulse laser, trans-foveal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yellow MPL
Arm Type
Active Comparator
Arm Title
Diode MPL
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Yellow micro-pulse laser
Intervention Description
applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
Intervention Type
Device
Intervention Name(s)
Diode micro-pulse laser
Intervention Description
applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Primary Outcome Measure Information:
Title
Change in Central Retinal Thickness (CRT)
Description
detecting changes in the thickness of the center of the macula
Time Frame
baseline, at 1 month and 3 months after the intervention
Title
Change in the Best Corrected Visual Acuity (BCVA)
Description
detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.
Time Frame
baseline, at 1 month and 3 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
bilateral diabetic macular edema
center involving confirmed by Optical coherence tomogram (OCT)
Exclusion Criteria:
any non-diabetic macular edema
significant media opacities
previous laser treatment, any intraocular surgery within the past 6 months
previous intravitreal injections of any drug within the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany S Hamza, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Individual participant data (IPD) can be shared with researchers who are planning to conduct a similar study. Requests can be sent to the central contacts by email
Citations:
PubMed Identifier
25719988
Citation
Vujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.
Results Reference
background
PubMed Identifier
28540655
Citation
Scholz P, Altay L, Fauser S. A Review of Subthreshold Micropulse Laser for Treatment of Macular Disorders. Adv Ther. 2017 Jul;34(7):1528-1555. doi: 10.1007/s12325-017-0559-y. Epub 2017 May 24.
Results Reference
background
Learn more about this trial
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
We'll reach out to this number within 24 hrs