NCT04505306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 2, 2020

Last Update Submit

August 5, 2020

Conditions

Diabetic Macular Edema

Keywords

micropulse laser

Outcome Measures

Primary Outcomes (2)

  • Central foveal thickness

    All 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.

    6 months

  • Best corrected visual acuity

    ETDRS visual acuity charts

    6 months

Study Arms (3)

Subthreshold Laser 30%

ACTIVE COMPARATOR

Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with 30% EndPoint algorithm.

Procedure: Macular Laser

Subtreshold Laser 50%

ACTIVE COMPARATOR

Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with 50% EndPoint algorithm.

Procedure: Macular Laser

Micropulse Laser

ACTIVE COMPARATOR

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.

Procedure: Macular Laser

Interventions

Macular LaserPROCEDURE

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.

Micropulse LaserSubthreshold Laser 30%Subtreshold Laser 50%

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital Centre

Abu Dhabi, United Arab Emirates

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Vitreoretinal Surgeon/Clinical Lead

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 10, 2020

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)