Diabetic Retinopathy Clinical Trial
Official title:
The Effect of Laser Pan-retinal Photocoagulation on Macular Pigment Optical Density in Cases With Diabetic Retinopathy
It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect macular pigment as well as inner layer cells in the retina, so it was aimed to investigate possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical density in diabetic retinopathy patients without macular edema and pathology in this study.
The local authorized clinical trials ethics committee approved the study and this study was
performed following the principles of the Declaration of Helsinki (2008). Detailed
information was given to patients about clinical applications and tests, and signed informed
consent forms were also obtained from all patients. The 36 eyes of 36 patients, scheduled
for laser pan-retinal photocoagulation treatment, with newly diagnosed proliferative
diabetic retinopathy without macular edema or scarring between October 2015 - June 2016 were
included in this sequential self-controlled clinical trial. Proliferative diabetic
retinopathy was diagnosed with determination of neovascular proliferations is either on the
disc (NVD) or elsewhere (NVE) except macular area in fundus examination with 90-diopter lens
and fundus fluorescein angiography (FFA) (Heidelberg Spectralis, Heidelberg Engineering,
Baden-Württemberg, Germany). Patients, detected macular fluid or edema by optical coherence
tomography (OCT) (Cirrus HD 4000, Carl Zeis Meditec, CA, USA) in study eye, were excluded in
the study. After providing information to patients about the disease and treatment;
patients, predicted to show adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Firstly, visual acuity was
recorded, and best-corrected visual acuity (BCVA) assessed using Snellen's chart and was
converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
After maximal pupil dilatation was achieved using 1% tropicamide and 10% phenylephrine eye
drops, put once or twice, at ten minute intervals, slit-lamp examination was performed, and
fundus was examined with 90-diopter indirect non-contact fundus lens, and ocular finds were
recorded.
Prior to measurements the pupil was dilated to at least 7 mm diameter using a topical
mydriatic agent. Macular pigment optical density (MPOD) levels were measured in the study
eye using luminance differential thresholds test (MonPack System®, Metrovision, Perenchies,
France), color perimetry technique at baseline before first PRP laser treatment and every
month before laser treatment until the end of this study. The macular pigment absorbs blue
light, and luminance differential thresholds test evaluates the density of the macular
pigment by comparing the thresholds of perception of blue light and red light with a
staircase technique similar to the technique used in automated perimetry. Luminance
differential thresholds were measured for 2 stimuli: a blue stimulus (450-480 nm) absorbed
by the MP, and a red one (615 nm) not absorbed. The stimuli were presented at the fovea and
at 6 peripheral locations with an eccentricity of 3 to 10 degrees (0°, 0.8°, 1.8°, 2.8° and
3.8°, and the average of two measurements at 6.8° and 7.8° retinal eccentricity serves as
the peripheral reference point). Tests parameters were Goldmann size III over a white
background of 10 cd.m-2. The average values of the tested (decibel=dB) were converted to
logarithm units (log unit) for statistical analysis (dB = 10log10 (Reference1/Reference2)).
Because, decibel is always the comparison between two values. As a result, the decibel
number is the same, although the measured power value is often different. Therefore,
arithmetic operations with the numbers expressed in decibels would be inconvenient.
Conventional laser PRP treatments were performed under topical anesthesia by using green
laser photocoagulator (GYC-500 Vixi® Nidek, Gamagori, Japan) and Volk® quadraspheric lens.
PRP laser were applied in 300mW power, 200-400-500 μm spot size and 0.1-0.2 second pulse
options, based upon preferences and comfort levels. When a pattern array was used, the spot
separation was set at 0.5 times the burn width.
Laser parameters were evaluated based on a) area (A) (= πr2 × number of shots) r being the
spot radius, which is half of the spot size (100-200-250 μm), and it was converted to square
millimeters (mm2) for statistical analyses, b) treatment duration (t) (= 0.1 - 0.2 second ×
number of shots) and c) total energy (E) (= P × t) milijoules (mJ) P being the power, which
is 300mW.
All examinations, MPOD and laser PRP parameters were repeated and recorded at 1st, 2nd, 3rd
month before laser treatments and 6th month. Changes in the eating habits of patients were
questioned at all study visits. All subjects were told to continue their normal diet, as no
subjects were consuming supplements containing lutein or zeaxanthin.
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