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The Effect of Laser Treatment on Macular Pigment of Eye in Cases With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03150654
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
Afyon Kocatepe University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Retinal Degeneration Macula Abnormality Laser Burn of Retina Device: Laser pan-retinal photocoagulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Sequential Assignment
Intervention Model Description: sequential self-controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Laser Pan-retinal Photocoagulation on Macular Pigment Optical Density in Cases With Diabetic Retinopathy
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : June 8, 2016
Actual Study Completion Date : July 12, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Laser pan-retinal photocoagulation
Conventional laser pan-retinal photocoagulations were performed by using green laser photocoagulator, every month for 3 months
Device: Laser pan-retinal photocoagulation
Green laser photocoagulator
Other Name: GYC-500 Vixi

Primary Outcome Measures :
  1. Change macular pigment optical density from baseline at 6 months [ Time Frame: 1 month and 3 months ]
    Macular pigment optical density measures were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month

Secondary Outcome Measures :
  1. Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03150654

Sponsors and Collaborators
Afyon Kocatepe University Hospital
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Study Director: Mustafa Dogan, Asst. Prof. Afyon Kocatepe University Eye Clinics

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Responsible Party: Afyon Kocatepe University Hospital Identifier: NCT03150654    
Other Study ID Numbers: 2011-KAEK-2 2015/323
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Afyon Kocatepe University Hospital:
macular pigment
macular pigment optical density
diabetic retinopathy
laser pan-retinal photocoagulation
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases, Hereditary