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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02988752
• Other study ID #: COZ001
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 2, 2016
• Last updated: December 8, 2016
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: Clinica Oftamologica Zona Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.
• Optical Coherence Tomography
Measure C/D Ratio With OCT, Considered Gold Standard Equipment

Locations

Country	Name	City	State
Brazil	Clinica Oftalmologica Zona Sul	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Oftamologica Zona Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective C/D Ratio measure	To measure vertical cup to disc ratio in an objective way	One Year	Yes