Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04359771
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Macula Edema	Device: Yellow micro-pulse laser; Device: Diode micro-pulse laser	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Yellow Micropulse Laser 577-nm vs Infrared Diode Micropulse Laser 810-nm for the Treatment of Diabetic Macular Edema
• Actual Study Start Date: Jan 22, 2018
• Actual Primary Completion Date: Sep 25, 2018
• Actual Study Completion Date: Sep 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Yellow MPL	Device: Yellow micro-pulse laser; applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
Active Comparator: Diode MPL	Device: Diode micro-pulse laser; applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea

Outcome Measures

Primary Outcome Measures

1. Change in Central Retinal Thickness (CRT) [baseline, at 1 month and 3 months after the intervention]

   detecting changes in the thickness of the center of the macula

2. Change in the Best Corrected Visual Acuity (BCVA) [baseline, at 1 month and 3 months after the intervention]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Cairo University	Cairo		Egypt	11562

Sponsors and Collaborators

• Cairo University

Investigators

• Study Director: Hany S Hamza, MD, Cairo University

Study Documents (Full-Text)

• Study Protocol - Dec 10, 2017
• Statistical Analysis Plan - Dec 10, 2017

More Information

Publications

• 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. Review.
• 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.

• Responsible Party: Ahmed Abdelbaki, lecturer of ophthalmology, Cairo University
• ClinicalTrials.gov Identifier: NCT04359771
• Other Study ID Numbers: I-030416
• First Posted: Apr 24, 2020
• Last Update Posted: Jun 1, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Ahmed Abdelbaki, lecturer of ophthalmology, Cairo University: micro-pulse laser; trans-foveal
• Additional relevant MeSH terms: Macular Edema; Diabetic Retinopathy; Edema

Study Results

Participant Flow

Recruitment Details	one eye (Right) from each patient was assigned to one arm (yellow MPL) and the other eye (Left) of the same patient to the 2nd arm (diode MPL). Therefore, the total number of enrolled participants was 15 contributing to total of 30 eyes (units) i.e there were 15 participants contributing to 15 eyes in each arm of the study.

Arm/Group Title	Yellow MPL	Diode MPL
Arm/Group Description	Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea. One eye (right) of each participant was assigned to this group.	Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea. One eye (left) of each participant was assigned to this group.
Period Title: Overall Study
STARTED	15	15
COMPLETED	13	13
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Yellow MPL	Diode MPL	Total
Arm/Group Description	Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea	Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea	Total of all reporting groups
Overall Participants	13	13	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.23 (8.03)	58.23 (8.03)	58.23 (8.03)
Sex: Female, Male (Count of Participants)
Female	5 38.5%	5 38.5%	10 38.5%
Male	8 61.5%	8 61.5%	16 61.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Egypt	13 100%	13 100%	13 50%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yellow MPL	Diode MPL
Arm/Group Description	Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea	Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Measure Participants	13	13
Measure eyes	13	13
Baseline	384.62 (147.06)	374 (130.42)
1 month	349.15 (141.78)	357.62 (116.23)
3 months	321.92 (126.65)	339.69 (111.94)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yellow MPL	Diode MPL
Arm/Group Description	Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea	Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Measure Participants	13	13
Measure eyes	13	13
Baseline	0.68 (0.30)	0.58 (0.28)
1 month	0.60 (0.33)	0.57 (0.29)
3 months	0.55 (0.34)	0.52 (0.31)

Adverse Events

Time Frame	data were collected over 6 months
Adverse Event Reporting Description	the interventions used in the trial are localized to the eye with no systemic complications. in addition, no ocular serious events were reported
Arm/Group Title	Yellow MPL		Diode MPL
Arm/Group Description	Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea		Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
All Cause Mortality
	Yellow MPL		Diode MPL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Yellow MPL		Diode MPL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Yellow MPL		Diode MPL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.