Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641144
• Other study ID #: NLPD-ZOC
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Sun Yat-sen University
• Contact: Yajun Gong, Bachelor
• Phone: 15622253107
• Email: gongyaj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol	12 months
Secondary	Central Retinal Thickness	Central Retinal Thickness will be performed by optical coherence tomography(OCT)	12 months
Secondary	10°retinal sensitivity	Retinal sensitivity will be measured by microperimetry	12 months
Secondary	treatment time	treatment time is time from laser treatment beginning to end	1 hour
Secondary	Participants pain intensity	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) .	1 hour
Secondary	Number of laser spots within macular fovea	Number of laser spots within macular fovea will measured by foundus photograph	1 month