NCT04505306

Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema

Comparison of Short-pulse Subthreshold (532 nm) and Infrared Micropulse (810 nm) Macular Laser for Diabetic Macular Edema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Moorfields Eye Hospital Centre Abu Dhabi · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

When applied according to manufacturer recommendations, short-pulse system may yield more temporary reduction in edema while infrared micropulse system may yield slightly better functional outcomes.

Detailed description

Purpose: To assess both anatomic and functional outcomes between short-pulse continuous wavelength and infrared micropulse lasers in the treatment of DME. Materials and Methods: A prospective interventional study from tertiary care eye hospital - King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving diabetic macular edema were treated with subthreshold laser therapy. Patients in the micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA). Laser was applied according to manufacturer recommendations for MicroPulseTM in a confluent mode (low intensity/high density) to the entire area of the macular edema. Patients in the short-pulse group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn. Main outcome measures included best-corrected visual acuity (BCVA) and foveal thickness at baseline and the last follow-up visit.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
PROCEDURE	Macular Laser	All treatments were performed using SPCW EndPoint 30% and 50% protocols and STMP laser. Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle. Laser was applied in the confluent mode (low intensity/high density) to cover the entire area of the macular edema and leakage as imaged by OCT and/or fundus fluorescein angiography. Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn with one burn width apart. In both groups, subthreshold power was determined by titrating burn to light (barely visible) burn and switching to either micropulse mode with 15% duty cycle or 30% and 50% EndPoint value.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2020-08-10
• Last updated: 2020-08-10

Locations

1 site across 1 country: United Arab Emirates