NCT03641144

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 7, 2018

Last Update Submit

August 17, 2018

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edemanavigation laserlaser photocoagulation

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol

    12 months

Secondary Outcomes (5)

  • Central Retinal Thickness

    12 months

  • 10°retinal sensitivity

    12 months

  • treatment time

    1 hour

  • Participants pain intensity

    1 hour

  • Number of laser spots within macular fovea

    1 month

Study Arms (2)

Navigation laser

EXPERIMENTAL

Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern

Device: Navigation laser

Traditional laser

ACTIVE COMPARATOR

Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern

Device: Traditional laser

Interventions

Navigation laserDEVICE

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.

Also known as: Navigation laser photocoagulation treatment
Navigation laser
Traditional laserDEVICE

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.

Also known as: Traditional laser photocoagulation treatment
Traditional laser

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

  • Chenjin Jin, Ph.D

    State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Yajun Gong, Bachelor

CONTACT

15622253107gongyaj@126.com

Chenjin Jin, Ph.D

CONTACT

13302209900jinchj@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor，Dr

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 21, 2018

Study Start

June 1, 2018

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

CN(1)