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

NCT03150654 | Completed DMC FDA Device

• 1 other identifier: 2011-KAEK-2 2015/323
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy; Retinal Degeneration; Macula Abnormality; Laser Burn of Retina

Keywords

macular pigment; macular pigment optical density; diabetic retinopathy; laser pan-retinal photocoagulation

Outcome Measures

Primary Outcomes (1)

• 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

  1 month and 3 months

Secondary Outcomes (1)

• Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months

  6 months

Study Arms (1)

Laser pan-retinal photocoagulation

EXPERIMENTAL

Conventional laser pan-retinal photocoagulations were performed by using green laser photocoagulator, every month for 3 months

Device: Laser pan-retinal photocoagulation

Interventions

Laser pan-retinal photocoagulation DEVICE

Green laser photocoagulator

Also known as: GYC-500 Vixi

Laser pan-retinal photocoagulation

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyon Kocatepe University Hospital: lead

Related Publications (15)

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• Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.

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MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Diseases, Hereditary

Study Officials

• Mustafa Dogan, Asst. Prof.

  Afyon Kocatepe University Eye Clinics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: sequential self-controlled clinical trial

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: October 1, 2015
• Primary Completion: June 8, 2016
• Study Completion: July 12, 2016
• Last Updated: May 12, 2017

Record last verified: 2017-05