Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

Not Applicable

• Conditions: Diabetic Macular Edema
• Interventions: Device: Traditional laser; Device: Navigation laser

• Registration Number: NCT03641144
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-06-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-17
• Last Update Submitted: 2018-08-17
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	12 months	Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol

Secondary Outcome Measures

Name	Time	Method
Central Retinal Thickness	12 months	Central Retinal Thickness will be performed by optical coherence tomography(OCT)
10°retinal sensitivity	12 months	Retinal sensitivity will be measured by microperimetry
treatment time	1 hour	treatment time is time from laser treatment beginning to end
Number of laser spots within macular fovea	1 month	Number of laser spots within macular fovea will measured by foundus photograph
Participants pain intensity	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) .

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China