Proliferative Diabetic Retinopathy - High Risk Clinical Trial
Official title:
Patient Comfort Using Green (532 nm) Versus Yellow (577 nm) Laser Indirect Ophthalmoscopy Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to achieve gray-white retinal burns and duration of treatment.
As demonstrated in the Diabetic Retinopathy Study (DRS), panretinal photocoagulation (PRP)
reduces the risk of severe vision loss in patients with proliferative diabetic retinopathy.
The DRS recommended that PRP treatment consist of 1,200 - 1,600 laser burns 500 µm in size,
one half to one burn width apart, applied to the peripheral retina in a scatter fashion.
Most patients who undergo PRP experience discomfort/pain during the procedure. Once present,
pain can affect the number and quality of burns delivered and can indirectly increase the
number of sessions required to complete the therapy.This may in turn adversely affect
patient compliance. Although retrobulbar and peribulbar blocks can provide adequate
anesthesia for PRP, these anesthetic methods carry rare but serious risks such as
retrobulbar hemorrhage. Previous studies have explored other ways to reduce discomfort
related to PRP, including optimization of laser settings, oral and topical analgesics,
subconjunctival anesthesia, and even acupuncture.
Currently, green lasers (521 - 532 nm wavelength) are most commonly utilized for performing
PRP in clinical practice. Yellow lasers (577 nm wavelength) have been of recent interest in
treating diabetic macular edema with micropulse subthreshold grid photocoagulation, but have
not been extensively studied in PRP for diabetic retinopathy. Compared to shorter wavelength
laser, yellow laser comports high transmission through dense ocular media and less light
scattering than shorter wavelengths which minimizes spot size and reduces thermal spread.
The limited literature comparing green and yellow laser for PRP in diabetic retinopathy has
shown that yellow laser requires less power to achieve a retinal burn. In theory this should
translate into a reduction in perceived pain experienced during PRP, however a comparison of
green and yellow lasers in this regard has not yet been directly examined and quantified.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment