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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Electronic Mobile Device
Optical Coherence Tomography
Sponsored by
Clinica Oftamologica Zona Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica Oftalmologica Zona Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electronic Mobile Device

Optical Coherence Tomography

Arm Description

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 considered as gold standard to determine c/d ratio. Needs mydriatic conditions.

Outcomes

Primary Outcome Measures

Objective C/D Ratio measure
To measure vertical cup to disc ratio in an objective way

Secondary Outcome Measures

Full Information

First Posted
June 2, 2016
Last Updated
December 8, 2016
Sponsor
Clinica Oftamologica Zona Sul
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1. Study Identification

Unique Protocol Identification Number
NCT02988752
Brief Title
Comparison Between an Electronic Mobile Device and Optical Coherence Tomography to Determine Cup-to-disc Ratio
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Oftamologica Zona Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Mobile Device
Arm Type
Experimental
Arm Description
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.
Arm Title
Optical Coherence Tomography
Arm Type
Active Comparator
Arm Description
Device considered as gold standard to determine c/d ratio. Needs mydriatic conditions.
Intervention Type
Device
Intervention Name(s)
Electronic Mobile Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography
Other Intervention Name(s)
OCT
Intervention Description
Measure C/D Ratio With OCT, Considered Gold Standard Equipment
Primary Outcome Measure Information:
Title
Objective C/D Ratio measure
Description
To measure vertical cup to disc ratio in an objective way
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANDREA SARMENTO
Organizational Affiliation
COZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Oftalmologica Zona Sul
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
51110000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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