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CTRI Number  CTRI/2026/03/106225 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on Adjusting Glasses to Improve Fit and Comfort for Young People with Down Syndrome 
Scientific Title of Study   Study on Facial Anthropometry and Frame Fit Using Fairbanks Gauge Among Spectacle Wearers in Patients with Down Syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saitirumaladev Kalicheti 
Designation  Assistant Professor 
Affiliation  Chitkara School of Health Sciences, Chitkara University 
Address  Chandigarh-Patiala National Highway (NH-7)
Rajpura
Patiala
PUNJAB
140401
India 
Phone  7386982580  
Fax    
Email  saitirumaladev@chitkara.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Saitirumaladev Kalicheti 
Designation  Assistant Professor 
Affiliation  Chitkara School of Health Sciences, Chitkara University 
Address  Chandigarh-Patiala National Highway (NH-7)
Rajpura

PUNJAB
140401
India 
Phone  7386982580  
Fax    
Email  saitirumaladev@chitkara.edu.in  
 
Details of Contact Person
Public Query  
Name  Saitirumaladev Kalicheti 
Designation  Assistant Professor 
Affiliation  Chitkara School of Health Sciences, Chitkara University 
Address  Chandigarh-Patiala National Highway (NH-7)
Rajpura

PUNJAB
140401
India 
Phone  7386982580  
Fax    
Email  saitirumaladev@chitkara.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Chitkara University 
Address  Chitkara School of Health Sciences, Chandigarh-Patiala National Highway (NH-7), Rajpura, Punjab 140401 
Type of Sponsor  Research institution 
 
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 
Sai Tirumaladev Kalicheti  Society for Rehabilitation of Mentally Challenged  Assessment Room, SOREM, Sector 36-C
Chandigarh
CHANDIGARH 		 7386982580

saitirumaladev@chitkara.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Human Ethical Committee, Chitkara University, Punjab  Approved 
NOC from Society for Rehabilitation of Mentally Challenged  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q909||Down syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1. Diagnosed with Down syndrome.

2. Current spectacle wearer (minimum 3 months duration).

3. Participant assent and Parental/LAR consent obtained 
 
ExclusionCriteria 
Details  1. Severe behavioral challenges preventing safe measurement.

2. History of facial trauma or surgery altering anatomy.

3. Broken or significantly damaged current spectacles. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantification of the "frame-face mismatch" by comparing 7 key facial anthropometric parameters (measured using the Fairbanks Facial Gauge) with current spectacle frame dimensions (measured using the ABDO Frame Rule).  As this is a cross-sectional observational study, participants are evaluated only once during a single 20-30 minute visit, with no follow-up period required. Therefore, the time points for both the primary and secondary outcomes have been updated to Day 1 to accurately reflect this single-assessment design. 
 
Secondary Outcome  
Outcome  TimePoints 
Immediate improvement in visual comfort and frame stability following on-the-spot minor frame adjustments (rectification).  Immediately following the primary assessment and rectification (Day 1). 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/04/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This cross-sectional observational study aims to evaluate facial measurements and assess spectacle frame fit using the Fairbanks Facial Gauge in fifty individuals with Down syndrome, aged 12 to 24 years. Standard spectacle frames often do not account for the unique facial differences in this population, such as a flattened nasal bridge, which leads to poor frame stability and discomfort. The study will measure current spectacle frame dimensions and compare them to the participants facial measurements to quantify the frame and face mismatch. If an ill-fitting frame is identified, researchers will perform minor on the spot optometric frame adjustments to improve patient comfort and visual compliance. The study will be conducted at SOREM in Chandigarh. The findings will provide immediate benefit to the participants and guide better eyewear design for this population in the future. 
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