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Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Macular Laser
Sponsored by
Moorfields Eye Hospital Centre Abu Dhabi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring micropulse laser

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moorfields Eye Hospital Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Subthreshold Laser 30%

Subtreshold Laser 50%

Micropulse Laser

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Best corrected visual acuity
ETDRS visual acuity charts

Secondary Outcome Measures

Full Information

First Posted
August 2, 2020
Last Updated
August 5, 2020
Sponsor
Moorfields Eye Hospital Centre Abu Dhabi
Collaborators
King Khaled Eye Specialist Hospital, University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT04505306
Brief Title
Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema
Official Title
Comparison of Short-pulse Subthreshold (532 nm) and Infrared Micropulse (810 nm) Macular Laser for Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moorfields Eye Hospital Centre Abu Dhabi
Collaborators
King Khaled Eye Specialist Hospital, University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
micropulse laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subthreshold Laser 30%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Subtreshold Laser 50%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Micropulse Laser
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Macular Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Central foveal thickness
Description
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.
Time Frame
6 months
Title
Best corrected visual acuity
Description
ETDRS visual acuity charts
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Moorfields Eye Hospital Centre
City
Abu Dhabi
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
No

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Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema

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