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Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT03641144
Recruitment Status : Unknown
Verified August 2018 by Jin Chen-jin, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
Best corrected visual acuity [ Time Frame: 12 months ]
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Central Retinal Thickness [ Time Frame: 12 months ]
    Central Retinal Thickness will be performed by optical coherence tomography(OCT)
  • 10°retinal sensitivity [ Time Frame: 12 months ]
    Retinal sensitivity will be measured by microperimetry
  • treatment time [ Time Frame: 1 hour ]
    treatment time is time from laser treatment beginning to end
  • 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) .
  • Number of laser spots within macular fovea [ Time Frame: 1 month ]
    Number of laser spots within macular fovea will measured by foundus photograph
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
Official Title  ICMJE Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema:A Prospective, Randomized, Paralleled Clinical Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • 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 Name: Navigation laser photocoagulation treatment
  • 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 Name: Traditional laser photocoagulation treatment
Study Arms  ICMJE
  • Experimental: Navigation laser
    Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
    Intervention: Device: Navigation laser
  • Active Comparator: Traditional laser
    Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
    Intervention: Device: Traditional laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641144
Other Study ID Numbers  ICMJE NLPD-ZOC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jin Chen-jin, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chenjin Jin, Ph.D State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP