Investigation of the Accuracy of a Low-cost, Portable, Au... | NCT03615612

Studies
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions

NCT03615612

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jul 21, 2020Actual

Enrollment

400Actual

Phase

Not Applicable

Conditions

Refractive Errors

Interventions

QuickSee refractive error assessment + glasses

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2017Actual

Primary Completion Date

Aug 2, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Jul 31, 2018

First Submission Date that Met QC Criteria

Jul 31, 2018

First Posted Date

Aug 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2020

Last Update Posted Date

Jul 21, 2020Actual

Name	Class
PlenOptika, Inc.	INDUSTRY
Aravind Eye Care System	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a double blind, case-crossover clinical trial.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OR Eyeglasses, then SR	Other	Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR)	Other: QuickSee refractive error assessment + glasses
SR Eyeglasses, then OR	Other	Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR)	Other: QuickSee refractive error assessment + glasses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QuickSee refractive error assessment + glasses	Other	QuickSee refractive error assessment + glasses	OR Eyeglasses, then SR SR Eyeglasses, then OR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Preference	Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Participants-

who visit a Vision Center for their eye check-up
who are aged between 18 years and 40 years

Exclusion Criteria: Participants-

whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D
who have a cylindrical power greater than 3 D
who have to travel long distances (beyond 10kms) to the hospital
who choose to buy spectacles that are priced more than Rs. 2000/- per pair
who have speech or hearing impairment
who do not speak the local language, Tamil
who do not want to purchase spectacles from AEH

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Friedman, MD, MPH, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aravind Eye Hospital		Madurai	Tamil Nadu		India

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

6 months

Access Criteria

PlenOptika, Aravind Eye Hospital, Johns Hopkins

URL

Not provided

ID	Term
D012030	Refractive Errors

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D005139	Eyeglasses

Ancestor Terms

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided