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CTRI Number  CTRI/2024/09/073773 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Clear vision for Kids: Assessing a New method for finding the perfect glasses. 
Scientific Title of Study   Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/​add-on Device  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT06524115  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramani Krishna Kumar 
Designation  Advisor, Optometry services 
Affiliation  Sankara Nethralaya Medical Research Foundation 
Address  Old No 18 New No 41 College road Nungambakkam Chennai 600006

Chennai
TAMIL NADU
600006
India 
Phone  9840312791  
Fax    
Email  kk@snmail.org  
 
Details of Contact Person
Scientific Query  
Name  Ramani Krishna Kumar 
Designation  Advisor, Optometry services 
Affiliation  Sankara Nethralaya Medical Research Foundation 
Address  Old No 18 New No 41 College road Nungambakkam Chennai 600006

Chennai
TAMIL NADU
600006
India 
Phone  9840312791  
Fax    
Email  kk@snmail.org  
 
Details of Contact Person
Public Query  
Name  Ramani Krishna Kumar 
Designation  Advisor, Optometry services 
Affiliation  Sankara Nethralaya Medical Research Foundation 
Address  Old No 18 New No 41 College road Nungambakkam Chennai 600006

Chennai
TAMIL NADU
600006
India 
Phone  9840312791  
Fax    
Email  kk@snmail.org  
 
Source of Monetary or Material Support  
Essilor International 147 rue de Paris, 94220 Charenton-le-Pont, France, 
 
Primary Sponsor  
Name  Essilor International 
Address  147 rue de Paris, 94220 Charenton-le-Pont, France 
Type of Sponsor  Other [Ophthalmic Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ronnie George  Sankara Nethralaya  Sankara Nethralaya Medical research Foudnation Old No 18 New No 41 College road Nungambakkam Chennai 600006
Chennai
TAMIL NADU 		 9841222890

kk@snmail.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vision Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H531||Subjective visual disturbances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Closed-Field autorefractometer  Closed-field autorefractometer without cycloplegia- Objective refraction, distance visual acuity with cycloplegia - Objective refraction, distance visual acuity 
Intervention  Photorefraction prototype device  Photorefraction device for 6 times for a duration of 18 minutes: Objective refraction without cycloplegia , distance visual acuity, photoretinoscopic images 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old
At least 6 years old and up to 12 years old at time of informed consent and assent
Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval [-10.00, +8.00]
Cylindrical refractive error between 0 and 4.00 D on both eyes
Corrected binocular visual acuity in distance vision at least 6/9 
 
ExclusionCriteria 
Details  Incapable of expressing consent
All categories of persons particularly protected by law
Subject in another study which might have an influence on vision or interfere with study assessment
Less than 6 years old, or 13 years old or above at time of informed consent and assent
Amblyopia, Cataract, Strabismus.
Aphakic or pseudophakic (intraocular implant)
Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye.
Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus)
Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…),
Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Objective refractive error
The refractive error is collected in sphere power (D), cylinder power (D) and cylinder axis (°) and converted in equivalent sphere, J0, J45 (power vector in D) 		 Baseline,
1 hour ( after intervention). 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 23/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device auto-refractometer with and without cycloplegia.
A single visit will be necessary. 
After informed consent and checking of the inclusion and exclusion criteria, investigators will perform measurements with an auto-refractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an auto refractometer under cycloplegia.
 
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