Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

August 17, 2018 updated by: Jin Chen-jin, Sun Yat-sen University

Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial

The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yajun Gong, Bachelor
  • Phone Number: 15622253107
  • Email: gongyaj@126.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥18 years
  • Diagnosed as diabetic retinopathy with Mild macular edema
  • BCVA≥0.5
  • No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months

Exclusion Criteria:

  • Blood glucose was not controlled steadily(HbA1cd≥10%)
  • Accompanied with severe hypertension（BP≥180/110mmHg）
  • Taking part in other clinical trial within 3 months
  • Planning panretinal photocoagulation(PRP) within 3 months
  • Performed cataract surgery in the last 3 months
  • Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
  • Accompanied with severe opacity of refractive media that maybe impact therapy and observation
  • Accompanied with nystagmus
  • Accompanied with some history that maybe interfere with result or increase the risk of patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navigation laser
Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Device: Navigation laser
Navigation laser device is a scanning slit-based instrument.before treatment the surgeon plan laser spots on the screen based on image(infrared, colour, fluorescein angiography)and then apply automated patterns and single spots as appropriate.the device will automatically carry out the plan.
Other Names:
  • Navigation laser photocoagulation treatment
Active Comparator: Traditional laser
Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Device: Traditional laser
Traditional laser is a slitlamp based instrument.Surgeon operate traditional laer device while watching Participant's image(infrared, colour, fluorescein angiography) and then manually aim at and trigger laser.
Other Names:
  • Traditional laser photocoagulation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: 12 months
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Retinal Thickness
Time Frame: 12 months
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
12 months
10°retinal sensitivity
Time Frame: 12 months
Retinal sensitivity will be measured by microperimetry
12 months
treatment time
Time Frame: 1 hour
treatment time is time from laser treatment beginning to end
1 hour
Participants pain intensity
Time Frame: 1 hour
Participants pain intensity will be immediately measured by Visual Analogue Scale/Score （VAS）after treatment.The VAS is a straight horizontal line of fixed length（100 mm）. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (0) to the right (100).The patient marks on the line the point that participants feel represents their perception of their current pain intensity.the VAS score is determined by measuring the distance (mm) on the 100mm line between the "0" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) .
1 hour
Number of laser spots within macular fovea
Time Frame: 1 month
Number of laser spots within macular fovea will measured by foundus photograph
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Chenjin Jin, Ph.D, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NLPD-ZOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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