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CTRI Number  CTRI/2026/01/102350 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Visual Disturbances in Eyes with Excellent Vision 
Scientific Title of Study   PREVALENCE AND TYPES OF ABERRATIONS IN EYES WITH SUPERVISION 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SRI GANESH  
Designation  Chief Medical Director  
Affiliation  Nethradhama superspeciality eye hospital  
Address  Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru Bangalore KARNATAKA

Bangalore
KARNATAKA
560070
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  DR SOWMYA G  
Designation  Phaco & Refractive surgery 
Affiliation  Nethradhama superspeciality eye hospital  
Address  Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division,256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru Bangalore KARNATAKA

Bangalore
KARNATAKA
560070
India 
Phone  8147310351  
Fax    
Email  sowmya2112sr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SAVIO PERERIA  
Designation  consultant 
Affiliation  Nethradhama superspeciality eye hospital  
Address  Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division,256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru Bangalore KARNATAKA

Bangalore
KARNATAKA
560070
India 
Phone  9869921301  
Fax    
Email  dr.savio.pereira@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070  
 
Primary Sponsor  
Name  Nethradhama superspeciality eye hospital  
Address  Nethradhama superspeciality eye hospital, Kanakapura road, 7th block, Jayanagar, Bengaluru, Karnataka, India, 560070  
Type of Sponsor  Private hospital/clinic 
 
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 SOWMYA G   Nethradhama superspeciality eye hospital   Department of Phaco and Refractive services, 256/14, Kanakapura main road, 7th block Jayanagar, Bengaluru. Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 
8147310351

sowmya2112sr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H527||Unspecified disorder of refraction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  All patients with UCVA 6/4 or better.
All patients with BCVA 6/4 or better.
Patients with 6/4 or better vision status post corneal refractive procedure.
 
 
ExclusionCriteria 
Details  Any ocular pathology (keratoconus, corneal scars, cataract, glaucoma, retinal disease)
Prior cataract surgery
Contact lens wear within the last 48 hours (soft) / 2 weeks (RGP)
Systemic diseases affecting the eye
Poor fixation, inability to perform iTrace scan
Pupillary abnormality
Dry eyes or ocular surface diseases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Mean and distribution of total, corneal, and internal HOA RMS values in super-normal–vision eyes.  • Mean and distribution of total, corneal, and internal HOA RMS values in super-normal–vision eyes. 
 
Secondary Outcome  
Outcome  TimePoints 
• Relationship between individual HOAs and UCVA (correlation analysis).
• Differences in HOA patterns across refractive groups.
• Proportion of subjects with “favorable” HOA profiles (e.g., negative spherical aberration).
 
 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   12/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patient preparation and examination:

 

  1. Full ophthalmic examination: Perform standard comprehensive eye exam including

·       Refractive status- UCVA, BCVA

·       Slit lamp examination, IOP and Dilated fundus examination

 

  1. Aberrometry (Primary Test)(HOYA Itrace surgical workstation USA)

    Key parameters captured:

·       Total HOA (RMS)

·       Corneal HOA (RMS)

·       Internal HOA (RMS)

·       Zernike coefficients up to 6th order

·       Specific aberrations of interest:

o   Coma (vertical, horizontal)

o   Trefoil

o   Spherical aberration

o   Secondary astigmatism

· Topography

·       Placido-disc corneal topography from iTrace

·       Keratometry values

·       Cone-like irregularities (if any)

· Quality Control

·       Minimum of 3 scans per eye, best-quality scan used

·       Pupil size documented for each scan

 

 

Participants will be divided based on their refractive status into:

Group 1: untreated UCVA 6/4 or better

Group 2: BCVA 6/4 or better

Group 3: post corneal refractive surgery with 6/4 or better

 

OUTCOME MEASURES

Primary Outcome

  • Mean and distribution of total, corneal, and internal HOA RMS values in super-normal–vision eyes.

Secondary Outcomes

  • Relationship between individual HOAs and UCVA (correlation analysis).
  • Differences in HOA patterns across refractive groups.
  • Proportion of subjects with “favorable” HOA profiles (e.g., negative spherical aberration).

 

 

 

 

DATA COLLECTION AND EXTRACTION:

 

Data should be extracted from iTrace software reports and recorded in study database (eg excel, red cap)

       Patient demographics: Age, gender, study ID;

       Refractive data (low order aberrations LOA); Aberration metrics: record the root mean square values for relevant aberrations, typically for a fixed pupil diameter.

 

 

 

 

 

STATISTICAL ANALYSIS METHODOLOGY:

All analyses will be conducted using Python (v3.12) and Jamovi (v2.5). Group differences will be assessed using a one-way fixed-effect ANOVA, with normality evaluated using the Kolmogorov–Smirnov test and homogeneity of variances tested using Levene’s test. Continuous data will be presented as mean ± SD, and categorical data as frequencies and percentages. When the ANOVA is significant, Bonferroni-adjusted post hoc tests will be performed. When normality assumptions are not met, appropriate non-parametric tests will be applied. A two-tailed p-value < 0.05 will be considered statistically significant.

 
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