The Effect of Laser Treatment on Macular Pigment of Eye in Cases With Diabetes
Primary Purpose
Diabetic Retinopathy, Retinal Degeneration, Macula Abnormality
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser pan-retinal photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring macular pigment, macular pigment optical density, diabetic retinopathy, laser pan-retinal photocoagulation
Eligibility Criteria
Inclusion Criteria:
- Best corrected visual acuity (BCVA) logMAR ≤0.4
- Newly diagnosis of PDR and initiation of conventional laser PRP treatment
- Between the ages of 40 and 65 years (40≤age≤65)
Exclusion Criteria:
- Corneal scarring, cataract or intravitreal hemorrhage that prevents appearance of the fundus
- Presence of macular pathologies such as AMD or choroidopathy
- Presence of macular edema or NVE in the macular area
- Detection of macular fluid or edema in OCT or FFA
- Previous laser PRP treatments
- Focal and / or grid photocoagulation requirements
- Previous refractive or vitreoretinal surgery
- Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
- Systemic diseases that may affect the choroidal blood flow such as cardiological diseases
- Current use of carotenoid supplementation
- Changing eating habits
- Gastrointestinal diseases that could cause disturbance of dietary absorption
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser pan-retinal photocoagulation
Arm Description
Conventional laser pan-retinal photocoagulations were performed by using green laser photocoagulator, every month for 3 months
Outcomes
Primary Outcome Measures
Change macular pigment optical density from baseline at 6 months
Macular pigment optical density measures were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month
Secondary Outcome Measures
Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months
The correlations between macular pigment optical density outcomes and panretinal laser photocoagulation parameters (total energy, total area, total shots, total duration) were evaluated for 6 months
Full Information
NCT ID
NCT03150654
First Posted
May 8, 2017
Last Updated
May 10, 2017
Sponsor
Afyon Kocatepe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03150654
Brief Title
The Effect of Laser Treatment on Macular Pigment of Eye in Cases With Diabetes
Official Title
The Effect of Laser Pan-retinal Photocoagulation on Macular Pigment Optical Density in Cases With Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
June 8, 2016 (Actual)
Study Completion Date
July 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Afyon Kocatepe University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Degeneration, Macula Abnormality, Laser Burn of Retina
Keywords
macular pigment, macular pigment optical density, diabetic retinopathy, laser pan-retinal photocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
sequential self-controlled clinical trial
Masking
None (Open Label)
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser pan-retinal photocoagulation
Arm Type
Experimental
Arm Description
Conventional laser pan-retinal photocoagulations were performed by using green laser photocoagulator, every month for 3 months
Intervention Type
Device
Intervention Name(s)
Laser pan-retinal photocoagulation
Other Intervention Name(s)
GYC-500 Vixi
Intervention Description
Green laser photocoagulator
Primary Outcome Measure Information:
Title
Change macular pigment optical density from baseline at 6 months
Description
Macular pigment optical density measures were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month
Time Frame
1 month and 3 months
Secondary Outcome Measure Information:
Title
Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months
Description
The correlations between macular pigment optical density outcomes and panretinal laser photocoagulation parameters (total energy, total area, total shots, total duration) were evaluated for 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Best corrected visual acuity (BCVA) logMAR ≤0.4
Newly diagnosis of PDR and initiation of conventional laser PRP treatment
Between the ages of 40 and 65 years (40≤age≤65)
Exclusion Criteria:
Corneal scarring, cataract or intravitreal hemorrhage that prevents appearance of the fundus
Presence of macular pathologies such as AMD or choroidopathy
Presence of macular edema or NVE in the macular area
Detection of macular fluid or edema in OCT or FFA
Previous laser PRP treatments
Focal and / or grid photocoagulation requirements
Previous refractive or vitreoretinal surgery
Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
Systemic diseases that may affect the choroidal blood flow such as cardiological diseases
Current use of carotenoid supplementation
Changing eating habits
Gastrointestinal diseases that could cause disturbance of dietary absorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Dogan, Asst. Prof.
Organizational Affiliation
Afyon Kocatepe University Eye Clinics
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Laser Treatment on Macular Pigment of Eye in Cases With Diabetes
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