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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04505306
Enrollment
113
Registered
2020-08-10
Start date
2015-01-01
Completion date
2017-01-01
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

micropulse laser

Brief 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.

Interventions

PROCEDUREMacular 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.

Sponsors

King Khaled Eye Specialist Hospital
CollaboratorOTHER_GOV
University of Nebraska
CollaboratorOTHER
Moorfields Eye Hospital Centre Abu Dhabi
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* center-involving clinically significant macular edema due to diabetic retinopathy (\>300 microns) * clear ocular media * ETDRS visual acuity \>29 letters (Snellen equivalent of 20/150) or better * treatment naïve eyes or previously treated with antiangiogenic intravitreal agent(s) more than 6 months ago to allow for long wash-out period

Exclusion criteria

* non-center involving diabetic macular edema * previous retinal laser or surgery * intravitreal steroid use * any condition that may be associated with a risk of macular edema such as age-related macular degeneration, retinal vein occlusion, vitreomacular traction, epiretinal membrane and others.

Design outcomes

Primary

MeasureTime frameDescription
Central foveal thickness6 monthsAll patients had central retinal thickness measurement using spectral-domain optical coherence tomography (SD-OCT)(Spectralis, Heidelberg Engineering, Heidelberg, Germany). The SD-OCT B-scan was based on the Spectralis macular raster consisting of 19 horizontals 6 millimeter line scans and a real-time eye tracking system.
Best corrected visual acuity6 monthsETDRS visual acuity charts

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026