Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

Official title:

Yellow Micropulse Laser 577-nm vs Infrared Diode Micropulse Laser 810-nm for the Treatment of Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359771
• Other study ID #: I-030416
• Status: Completed
• Phase: Phase 4
• Start date: January 22, 2018
• Est. completion date: September 25, 2018

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 25, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macula Edema
• Macular Edema

Intervention

Device:
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Central Retinal Thickness (CRT)	detecting changes in the thickness of the center of the macula	baseline, at 1 month and 3 months after the intervention
Primary	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.	baseline, at 1 month and 3 months after the intervention