| CTRI Number |
CTRI/2025/03/081823 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Eye Test Software to Measure Suppression size and depth in Lazy Eye |
|
Scientific Title of Study
|
Development of a stand-alone software tool for quantitative measurement of suppression size and depth in
amblyopia and its association with visual acuity and stereoacuity in Anisometropic Amblyopia |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srividhya L |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah University of Applied Sciences |
| Address |
Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar Bangalore KARNATAKA 560054 India |
| Phone |
9632027883 |
| Fax |
|
| Email |
srividhya.ah.ls@msruas.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Srividhya L |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah University of Applied Sciences |
| Address |
Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar Bangalore KARNATAKA 560054 India |
| Phone |
9632027883 |
| Fax |
|
| Email |
srividhya.ah.ls@msruas.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Srividhya L |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah University of Applied Sciences |
| Address |
Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar Bangalore KARNATAKA 560054 India |
| Phone |
9632027883 |
| Fax |
|
| Email |
srividhya.ah.ls@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Ramaiah Medical College Hospital, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bangalore - 560054 |
|
|
Primary Sponsor
|
| Name |
Srividhya L |
| Address |
Assistant Professor, Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bengaluru 560054 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Ananth S Bhandary |
M S RAMAIAH MEDICAL COLLEGE HOSPITAL |
Department of Ophthalmology, Optometry Division, Room 3, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 Bangalore KARNATAKA |
9845832789
ananthbhandary.rmc@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The University Ethics Committee for Human trials of M S Ramaiah University of Applied Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H530||Amblyopia ex anopsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with amblyopia aged between 10 to 40 years and cooperative in the assessments of interocular suppression. |
|
| ExclusionCriteria |
| Details |
Amblyopic patients with strabismus associated with ocular albinism, diplopia, or a medical
history of seizures are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantification of suppression size and depth in amblyopia using a newly developed clinical tool, measured in terms of the visual angle (degrees) over which suppression occurs and the contrast difference required to overcome suppression |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association of suppression size (in terms of visual angle) and suppression depth (in terms of difference in contrast between amblyopic eye and fellow fixing eye) and visual acuity in individuals with aniso myopic and aniso hypermetropic amblyopia |
10 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/03/2025 |
| 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="1" Months="10" 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
|
Amblyopia is a neurodevelopmental abnormality that results in impaired visual acuity as well as stereopsis, and contrast sensitivity in one eye or in both due to physiological alterations in the visual pathways. Amblyopia could be clinically classified based on etiology as strabismic(misalignment of the eyes) amblyopia, anisometropic amblyopia (clinically significant difference of about 2 dioptre between the eyes) and mixed amblyopia (presence of both strabismus and anisometropia). Interocular Suppression plays a key role in visual deficit in Amblyopia. Amblyopic Suppression in relation to binocular vision refers to an inhibitory effect of the fellow eye over the amblyopic eye when both eyes are viewing. The characteristics of suppression in different types of amblyopia and the association of the suppression size and depth with the visual acuity loss and stereoacuity loss in amblyopia is not well understood. The currently available clinical tests for quantifying suppression are binary (presence or absence of suppression), rudimentary, and have limitations of test-retest reliability. While current amblyopia management focuses on visual acuity and stereoacuity improvements, changes in suppression are not systematically quantified. The interplay between visual acuity enhancement through amblyopia treatment and alterations in suppression size or depth remains inadequately explored. This advocates the need to develop a clinical tool to quantify suppression size and depth in clinical practice. Quantifying the suppression size and depth in amblyopia needs to be established in clinical practice and also it could provide insights into the changes in characteristics of suppression during amblyopia treatment. This could be further researched to get an effective monitoring of different management plans for amblyopia like patching, binocular therapies and anti-suppression therapy. Quantifying suppression size and depth would also provide a method to rank the amblyopes with nil stereo acuity. Thus a tool for the clinical quantification of suppression size and depth in amblyopia needs to be developed and validated. This research aims to fill this gap by developing a clinically viable tool for quantifying suppression size and depth in amblyopia. The proposed study seeks to establish the clinical utility of quantifying suppression characteristics, offering insights into dynamic changes during amblyopia treatment. This research could potentially pave the way for more effective monitoring and tailored management strategies for different amblyopic subtypes. Moreover, the exploration of suppression size and depth in association with visual acuity and stereoacuity loss in anisometropic amblyopia, specifically aniso-myopic and aniso-hypermetropic amblyopia, adds a novel dimension to this study.
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