Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

Sun Yat-sen University

Status: Unknown

Conditions: Diabetic Macular Edema

Treatments: Device: Navigation laser; Device: Traditional laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03641144

NLPD-ZOC

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Navigation laser

Experimental group

Description:

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

Treatment:

Device: Navigation laser

Traditional laser

Active Comparator group

Description:

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

Treatment:

Device: Traditional laser