Comparison Between an Electronic Mobile Device and Optical Coherence Tomography to Determine Cup-to-disc Ratio

Comparison Between an Electronic Mobile Device(DEM) and Optical Coherence Tomography (OCT) to Determine Cup-to-disc Ratio (C/D) Through a Non-inferiority Trial With Masked Data Analysis

This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18 to 60 years from both genders that met the pre-defined criteria were included. This study was carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE. Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each eye of the individuals, under midriatic conditions. Evaluations were done by examiners who did not know previously results obtained from other equipment. Data was collected by the main researcher of this research. This study was approved by the ethics committee before it started and all research members signed the TCLE agreement. The statistical test employed in this study was Pearson Correlation test.

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Device: Electronic Mobile Device; Device: Optical Coherence Tomography

Detailed Description

Glaucoma is the second major cause of blindness in the world, lagging only behind cataract. However, unlike cataract, blindness caused by glaucoma is irreversible. Early diagnosis of the disease and progression monitoring is thus essential for proper treatment in order to avoid irreversible blindness. The most common screening exam for glaucoma diagnosis and monitoring is the eye fundus evaluation where Cup-to-Disc ratio (CDR) among other parameters are assessed. This kind of evaluation is performed by ophthalmologists based on their visual perception, requiring not only specific training but also some significant amount of time of eye examination.Objective measurement of CDR involves high cost equipment which in turn requires some specific training in order to use them. Currently, the Optical Coherence Tomography is used as the gold standard for CDR measurement. An OCT exam uses a high cost and complex equipment that most of the time is not affordable for low-income people. This study proposes a portable electronic device that captures eye fundus images, analyzes these images, performs CDR calculation and allows storing these images for further analysis. This low cost and portable device was developed to be used in several health services (public or private) and has low energy consumption, easing its mobility. Moreover, using this device is easy, not requiring any significant learning effort from ophthalmologists. In developing countries where screening programs for early diagnosis of glaucomatous neuropathy are adopted, an ever-growing number of researchers are putting a significant amount of effort to develop cost-benefit solutions that can reach low-income people and remote areas.

Objective: This study compared CDR measurements from the portable electronic device (PED) developed by Centro de Informatica da Universidade Federal de Pernambuco to CDR measurements provided by OCT.

Methods:This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18 to 60 years from both genders that met the pre-defined criteria were included. This study was carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE. Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each eye of the individuals, under midriatic conditions. Evaluations were done by examiners who did not know previously results obtained from other equipment. Data was collected by the main researcher of this research. This study was approved by the ethics committee before it started and all research members signed the TCLE agreement. The statistical test employed in this study was Pearson Correlation test.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 51110000
      • Clínica Oftalmológica Zona Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anyone from 18 to 60 Years old without any of the Specified Exclusion Criteria.

Exclusion Criteria:

• Cancer
• Cataract
• Eyes transparency loss
• Best Av < 0.4
• Eye surgery in the last 12 Months
• Use of drugs that leads to any kind of Neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic Mobile Device; Use an Electronic Low Cost Mobile Device To Determine C/D Ratio And Compare Results With Gold Standard Optical Coherence Tomography Results. The equipment needs mydriatic conditions and does not touch the patient's eye. The equipment uses a panoptik and a camera to access eye fundus.	Device: Electronic Mobile Device; Measure C/D Ratio With An Equipment Attached To A Ophthalmoscope That Will Determine C/D Ratio Without Touching Patient's Eyes. To Perform It We Need Mydriatic Conditions.
Active Comparator: Optical Coherence Tomography; Device considered as gold standard to determine c/d ratio. Needs mydriatic conditions.	Device: Optical Coherence Tomography; Measure C/D Ratio With OCT, Considered Gold Standard Equipment; Other Names: OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective C/D Ratio measure	To measure vertical cup to disc ratio in an objective way	One Year

Collaborators and Investigators

• Sponsor: Clinica Oftamologica Zona Sul
• Investigators: Principal Investigator: ANDREA SARMENTO, COZ

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: COZ001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No