Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, navigation laser, laser photocoagulation
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 .
Interventions
DEVICENavigation 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.
DEVICETraditional 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 12 months | Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) . |
| Number of laser spots within macular fovea | 1 month | Number of laser spots within macular fovea will measured by foundus photograph |
Countries
China
Contacts
Primary ContactYajun Gong, Bachelor
Backup ContactChenjin Jin, Ph.D
Outcome results
None listed