Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04359771
Study type	Interventional
Source	Cairo University
Contact
Status	Completed
Phase	Phase 4
Start date	January 22, 2018
Completion date	September 25, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03660345` - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME	Phase 3
Completed	`NCT03660384` - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy	N/A
Completed	`NCT03660371` - ILM Peeling in PDR Patients Undergoing PPV for VH	N/A
Completed	`NCT04905459` - ARDA Software for the Detection of mtmDR
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03713268` - Intraoperative OCT Guidance of Intraocular Surgery II
Completed	`NCT05022615` - Comparing 3 Imaging Systems
Completed	`NCT00385333` - Metabolic Mapping to Measure Retinal Metabolism	Phase 2
Recruiting	`NCT04101604` - Biomarkers of Common Eye Diseases
Completed	`NCT03702374` - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy	Phase 3
Completed	`NCT01908816` - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.	Phase 3
Completed	`NCT04009980` - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.	N/A
Completed	`NCT02924311` - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting	`NCT06257082` - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities	N/A
Not yet recruiting	`NCT05452993` - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography	N/A
Withdrawn	`NCT02812030` - Aflibercept for Retinopathy in the Real World	N/A
Completed	`NCT02391558` - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography	N/A
Active, not recruiting	`NCT02330042` - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting	`NCT02353923` - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy	N/A
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.