Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2018-09-25

Brief Summary

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Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.

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Detailed Description

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This was a prospective randomized comparative study that included 30 eyes of 15 patients with bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital, Cairo University. The study's protocol was reviewed and approved by board of the ophthalmology department, Cairo University, and was in concordance with the tents of Declaration of Helsinki. Eligible patients were informed about the study's objectives, methodology, risks and benefits. A written informed consent was obtained from every patient included in this study.Preliminary examination was in the form of slit-lamp examination, fundus examination, intra ocular pressure measurement, and best corrected visual acuity (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to all patients before treatment to measure the central retinal thickness (CRT). The eyes were randomized into two groups; one eye (right eye) of each patient was treated with 577-nm yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL. Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.

Conditions

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Diabetic Retinopathy Macula Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yellow MPL

Group Type ACTIVE_COMPARATOR

Yellow micro-pulse laser

Intervention Type DEVICE

applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea

Diode MPL

Group Type ACTIVE_COMPARATOR

Diode micro-pulse laser

Intervention Type DEVICE

applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea

Interventions

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Yellow micro-pulse laser

applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea

Intervention Type DEVICE

Diode micro-pulse laser

applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bilateral diabetic macular edema
* center involving confirmed by Optical coherence tomogram (OCT)

Exclusion Criteria

* any non-diabetic macular edema
* significant media opacities
* previous laser treatment, any intraocular surgery within the past 6 months
* previous intravitreal injections of any drug within the past 6 months

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No