| 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
|
|
|
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
|
|
|
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:
- Full ophthalmic
examination: Perform standard comprehensive eye exam including
· Refractive status- UCVA, BCVA
· Slit lamp examination, IOP
and Dilated fundus examination
- 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. |