Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Choroidal Neovascularization
  • Diabetic Retinopathy
  • Healthy
  • Myopia
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This will be prospective cross-sectional study. This research will be done in the period between 1 August and 31 December 2020 and will include 80 eyes from patients with following disorders: Group 1: Patients with diabetic retinopathy Group 2: Patients with myopia Group 3: patients with choroidal n...

This will be prospective cross-sectional study. This research will be done in the period between 1 August and 31 December 2020 and will include 80 eyes from patients with following disorders: Group 1: Patients with diabetic retinopathy Group 2: Patients with myopia Group 3: patients with choroidal neovascularization Group 4: control eyes with no retinal disease. Inclusion criteria: Patients above 18 years in age with any of above retinal condition and clear media allowing for imaging will be included. Exclusion criteria will include; Maculopathies (hereditary or acquired), optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.), optic neuropathies (demyelinating, infectious, ischemic, etc.), adjusted IOP for central corneal thickness more than 21 mmHg, surgery-induced corneal edema and dense cataracts that can disrupt images, history of vasoactive agents (calcium antagonists, nitric oxide, etc.) use, systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.) and any previous ocular surgery, patients with bad quality images or complicated surgeries will be excluded. All patients will be subject to Full ophthalmologic examination and OCTA imaging. High-quality 3 x 3 mm and 6 x 6 mm OCTA macular scans and 4.5 × 4.5-mm papillary scan with strong signal-noise ratio and adequate centration on the fovea and optic nerve head respectively will be selected. For each patient 10 successive scans will be generated to allow for the analysis of repeatability. Patient will be imaged in the same day at two different OCTA devices Dri Triton (Topcon, Japan) and Cirrus OCT (Zeiss, USA) to investigate the reproducibility of the measurements. Automated segmentation will be used to evaluate super?cial and deep capillary retinal plexus projections. If errors in segmentation were detected, manual correction would be performed. The super?cial retinal capillary plexus (SCP) was delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) was segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL). In addition, the total retinal capillary plexus (TCP) was manually customized by selecting the inner boundary at the ILM and the outer boundary set at 40 µm above the retinal pigment epithelium (RPE) to avoid any ?ow signals from choriocapillaries. We will evaluate the following metric from enface OCT angiogram; vessel density, vessel density, intercapillary area, fractal dimension and skeletonized vessel density. Every included patient in this study will have unique code number referring to the file where all his data will be kept confidential. Only macula and optic disc will be imaged. Additionally, patients' personal data will be hidden during using of these images. All patients' data will be used for scientific research only and will be kept totally confidential. Comprehensive explanation of all aspects of this study will be given to patients before their participation in it, an informed consent will be obtained from the patients before their enrolment in the study. Although no documented adverse effects from OCTA imaging on the patients to date, however, any unexpected risks appeared during the research will be cleared to the participants and the ethical committee on time. Statistical analysis will be performed using SPSS software (version 25; SPSS, Inc., Chicago, IL, USA). the intraclass correlation coefficient (ICC) and coefficient of variation (CV) will be calculated. ICC is the correlation between two variables measured at the same time point, with values ranging from 0 to 1 (<0.40, poor; 0.40-0.59, fair; 0.60-0.74, good; 0.75-1.00, excellent). The CV (%) will be calculated as 100 × standard deviation/overall mean, and a value <10% represents good repeatability of the measurement.

Tracking Information

NCT #
NCT04488887
Collaborators
Not Provided
Investigators
Principal Investigator: Osama A Sorour, MD Tanta University