Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
Paskutinį kartą patikrinta: | 04/30/2020 |
Pirmasis pateikimas: | 04/20/2020 |
Numatytas registravimas pateiktas: | 04/21/2020 |
Pirmas paskelbtas: | 04/23/2020 |
Paskutinis atnaujinimas pateiktas: | 05/14/2020 |
Paskutinis atnaujinimas paskelbtas: | 05/31/2020 |
Pirmųjų rezultatų pateikimo data: | 05/02/2020 |
Pirmojo QC rezultatų pateikimo data: | 05/02/2020 |
Pirmųjų paskelbtų rezultatų data: | 05/17/2020 |
Faktinė studijų pradžios data: | 01/21/2018 |
Numatoma pirminio užbaigimo data: | 09/24/2018 |
Numatoma studijų užbaigimo data: | 09/24/2018 |
Būklė ar liga
Intervencija / gydymas
Device: Yellow MPL
Device: Diode MPL
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Active Comparator: Yellow MPL | Device: Yellow MPL applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea |
Active Comparator: Diode MPL | Device: Diode MPL applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 20 Years Į 20 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Change in Central Retinal Thickness (CRT) [baseline, at 1 month and 3 months after the intervention]
2. Change in the Best Corrected Visual Acuity (BCVA) [baseline, at 1 month and 3 months after the intervention]