Clinical trial NCT03641144: Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
Official title: Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
navigation laser
laser photocoagulation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility 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

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Central Retinal Thickness
timeFrame: 12 months
measure: 10°retinal sensitivity
timeFrame: 12 months
measure: treatment time
timeFrame: 1 hour
measure: Participants pain intensity
timeFrame: 1 hour
measure: Number of laser spots within macular fovea
timeFrame: 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin, Ph.D
role: STUDY_CHAIR
References: