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Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Device: Navigation laser Device: Traditional laser Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema:A Prospective, Randomized, Paralleled Clinical Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: 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 Name: Traditional laser photocoagulation treatment




Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 12 months ]
    Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol


Secondary Outcome Measures :
  1. Central Retinal Thickness [ Time Frame: 12 months ]
    Central Retinal Thickness will be performed by optical coherence tomography(OCT)

  2. 10°retinal sensitivity [ Time Frame: 12 months ]
    Retinal sensitivity will be measured by microperimetry

  3. treatment time [ Time Frame: 1 hour ]
    treatment time is time from laser treatment beginning to end

  4. 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) .

  5. Number of laser spots within macular fovea [ Time Frame: 1 month ]
    Number of laser spots within macular fovea will measured by foundus photograph



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641144


Contacts
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Contact: Yajun Gong, Bachelor 15622253107 gongyaj@126.com
Contact: Chenjin Jin, Ph.D 13302209900 jinchj@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yanjie Yan    +86-020-87332529    zocethics@163.com   
Contact: Chenjin Jin, Ph.D    13302209900    jinchj@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Chenjin Jin, Ph.D State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Jin Chen-jin, Professor,Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03641144    
Other Study ID Numbers: NLPD-ZOC
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin Chen-jin, Sun Yat-sen University:
Diabetic Macular Edema
navigation laser
laser photocoagulation
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases