Pattern Scan Laser System vs Regular Photocoagulation System: Changes in Electroretinograms and Contrast Sensitivity Post Treatment.
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Changes in a wave amplitude
Study Overview
Brief Summary
Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has become the treatment of choice in PDR. The aim is to destroy a substantial portion of the peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between oxygen demand and the administration). Their effectiveness is determined by the extent of destruction of the retina (2.4).
Detailed Description
Introduction:
The concept of retinal photocoagulation was introduced by Meyer-Schwickerath for treatment of diabetic retinopathy in the 50s (1, 6). The first successfully used laser was the arc xenon laser (polychromatic, inefficient, and hard to handle). Then the ruby and argon laser appeared (with mayor improvements in design and management). The modern era of photocoagulation as we know it began in the late 70s.
With these available technologies, the focal photocoagulation, the panretinal photocoagulation and the grid photocoagulation were developed. Witch proved effective for the treatment of severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy in different multicenter studies (ETDRS, DRS) (1.6).
Patients usually receive from 1200 to 1500 laser shots in 2 to 4 sessions lasting from 10 to 20 minutes, during 2 to 4 weeks. The procedure can be time consuming, tedious and painful.
Until now little has changed in the overall design of lasers of 30 years ago. The differences are the introduction of fibre optics and air-based cooling systems. These innovations do not have any impact on the way in which the treatment or the success.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 25 years, with a diagnosis of severe NPDR or PRD.
- •Good pupil mydriasis (minimum 5mm) With clear media
- •Patients without previous laser treatment or treatment with antiangiogenic drug.
Exclusion Criteria
- •Patients who do not accept informed consent.
- •Patients with clinical macular Edema before treatment.
- •Significant corneal opacity.
- •Patients with other eye diseases that interfere with the studies required for the monitoring of patients.
- •History of refractive surgery, glaucoma or ocular hypertension, intraocular inflammation, choroiditis multifocal, retinal detachment, optic neuropathy (4).
- •Patients with tractional retinal detachment due to abundant fibrovascular
Outcomes
Primary Outcomes
Changes in a wave amplitude
Time Frame: 12 weeks
changes in b wave amplitude
Time Frame: 12 weeks
changes in ERG implicit time
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported