| CTRI Number |
CTRI/2022/05/042464 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
09/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diagnostic Accuracy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing eye power measured by a person not trained in refraction versus the eye power measured by a person who is trained in refraction
|
|
Scientific Title of Study
|
Investigating accuracy of subjective refraction
performed by a trained non-refractionist compared
with an experienced refractionist in a high volume
eye hospital in southern India
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanil Joseph |
| Designation |
Senior Faculty |
| Affiliation |
Lions Aravind Institute of Community Ophthalmology (LAICO) |
| Address |
Lions Aravind Institute of Community Ophthalmology (LAICO),
Research Division,
72, Kuruvikaran Salai,
Gandhi Nagar, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9894279089 |
| Fax |
|
| Email |
sanil@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanil Joseph |
| Designation |
Senior Faculty |
| Affiliation |
Lions Aravind Institute of Community Ophthalmology (LAICO) |
| Address |
Lions Aravind Institute of Community Ophthalmology (LAICO),
Research Division,
72, Kuruvikaran Salai,
Gandhi Nagar, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9894279089 |
| Fax |
|
| Email |
sanil@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Sanil Joseph |
| Designation |
Senior Faculty |
| Affiliation |
Lions Aravind Institute of Community Ophthalmology (LAICO) |
| Address |
Lions Aravind Institute of Community Ophthalmology (LAICO),
Research Division,
72, Kuruvikaran Salai,
Gandhi Nagar, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9894279089 |
| Fax |
|
| Email |
sanil@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital
No.1 Anna Nagar, Madurai, 625020, TamilNadu. |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
No.1 Anna Nagar, Madurai, 625020, TamilNadu. |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sanil Joseph |
Aravind Eye Hospital |
Out Patient Unit-3,
General Ophthalmology,
No.1 Anna Nagar,
Madurai-625020
Madurai
TAMIL NADU |
9894279089
sanil@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H526||Other disorders of refraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
E-See Subjective |
Subjective refraction will be performed by the trained non refractionist |
| Comparator Agent |
Subjective Refreaction |
Subjective refraction will be performed by the trained refractionist |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Attending the general Ophthalmology units of AEH |
|
| ExclusionCriteria |
| Details |
1. Present with ocular injury or infections.
2. Are on medications that can influence the
refraction measurement.
3. Are physically or mentally challenged |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Refractive error |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Submission of the findings in a peer reviewed journal |
12 months |
|
|
Target Sample Size
|
Total Sample Size="420"
Sample Size from India="420"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we aim to validate a refractive error service model in which a non-refractionist, MLOP
performs subjective refraction with the support of
readings from a portable, low-cost autorefractor to generate accurate prescriptions for eyeglasses. The objective of the study was to
validate the accuracy of subjective refraction performed by
the non-refractionists MLOP compared with experienced refractionists.
| This
will be a diagnostic accuracy study in which every patient enrolled will
first undergo subjective refraction performed by an experienced refractionist
as per Aravind’s standard protocol. After this, a non-refractionist MLOP,
trained using the structured curriculum will perform autorefraction using
e-see autorefractor followed by subjective refraction. Glass prescriptions
generated by the trained non-refractionists (TNR) will be compared with that
by the experienced refractionist (gold standard) for accuracy as well as
patient preference. We would generate evidence to validate this approach of using
trained non-refractionist to perform refraction and issue glass prescriptions.
|
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