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CTRI Number  CTRI/2025/09/095397 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Tropicamide versus cyclopentolate for cycloplegic refraction in the paediatric population  
Scientific Title of Study   Efficacy of tropicamide 1% versus cyclopentolate 1% for cycloplegic refraction in the paediatric population of Eastern India: A crossover randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shoubhik Chakraborty 
Designation  Paediatric Optometrist Department of Ophthalmology, KIMS 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES , BHUBANESWAR 
Address  Room no F 30, department of Ophthalmology, KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS-5, KIIT ROAD,PATIA,BHUBANESWAR

Khordha
ORISSA
751024
India 
Phone  9002059793  
Fax    
Email  optomshoubik@gamil.com  
 
Details of Contact Person
Scientific Query  
Name  Shoubhik Chakraborty 
Designation  Paediatric Optometrist Department of Ophthalmology, KIMS 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES , BHUBANESWAR 
Address  Room no F 30, department of Ophthalmology, KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS-5, KIIT ROAD,PATIA,BHUBANESWAR

Khordha
ORISSA
751024
India 
Phone  9002059793  
Fax    
Email  optomshoubik@gamil.com  
 
Details of Contact Person
Public Query  
Name  Shoubhik Chakraborty 
Designation  Paediatric Optometrist Department of Ophthalmology, KIMS 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES , BHUBANESWAR 
Address  Room no F 30, department of Ophthalmology, KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS-5, KIIT ROAD,PATIA,BHUBANESWAR

Khordha
ORISSA
751024
India 
Phone  9002059793  
Fax    
Email  optomshoubik@gamil.com  
 
Source of Monetary or Material Support  
Department Of Ophthalmology , Kalinga Institute Of Medical Sciences , Campus-5 , KIIT Road , Patia , Bhubaneswar 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF SPONSORED] 
 
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 
SHOUBHIK CHAKRABORTY  DEPARTMENT OF OPHTHALMOLOGY , KIMS BHUBANESWAR  Room no F 30, department of Ophthalmology, KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS-5, KIIT ROAD,PATIA,BHUBANESWAR
Khordha
ORISSA 		 9002059793

optomshoubik@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , KIMS , BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H522||Astigmatism, (3) ICD-10 Condition: H520||Hypermetropia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cyclopentolate  1% Cyclopentolate eyedrops will be put in both eyes of the patient and mydriasis and cycloplegia done by the drug will be noted. 
Comparator Agent  Tropicamide  1% Cyclopentolate eyedrops will be put in both eyes of the patient and mydriasis and cycloplegia done by the drug will be noted. Edit || Delete  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 6–18 years
Children willing to and able to attend three visits and No known allergy to tropicamide or cyclopentolate
 
 
ExclusionCriteria 
Details  1. Children less than 6 years
2. Children are uncooperative for subjective acceptance
3. History of ocular surgery or trauma
4. Systemic illness requiring regular medication
5. Previous use of atropine or other cycloplegics in the past 3 months
6. Children with strabismus or nystagmus
7. Children with any neurological disorder
8. History of any drug use or ocular or systemic disorder that affects accommodation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1. Cycloplegic refractive error with 1% cyclopentolate
2. Cycloplegic refractive error with 1% tropicamide
 		 Group A initially receives cycloplegic refraction with 1% Cyclopentolate, followed by subjective acceptance testing after one week. After a washout period of one week, the same group undergoes cycloplegic refraction with 1% Tropicamide, followed again by subjective acceptance testing and vice versa for group B. 
 
Secondary Outcome  
Outcome  TimePoints 
Subjectively accepted spherical equivalent with 1% cyclopentolate versus 1% tropicamide  follow up 1 week later 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   Phase 4 
Date of First Enrollment (India)   10/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/10/2025 
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   Cycloplegic refraction is regarded as the gold standard procedure for prescribing glasses in children. Inadequate cycloplegic effect results in an under-plus or over-minus refractive correction. Additionally, procedure time is a crucial factor in determining the ideal cycloplegic agent. Children typically have fluctuating accommodation, which can lead to errors in the objective estimation of refractive errors. Therefore, cycloplegia is needed to relax accommodation, which is achieved by instilling cycloplegic agents. A high amplitude of accommodation is the primary cause of variability in pediatric subjects. Hypermetropic refractive errors vary more than myopia and emmetropia. Inhibition of the acetylcholine present in the ciliary body causes paralysis of the ciliary muscles, cycloplegia, and dilation of the pupil, known as mydriasis. The clinician selects different cycloplegic agents based on factors such as the presence or absence of strabismus, type of refractive error, previous history of drug allergies, and the age of the subjects. 1% Cyclopentolate is a cycloplegic agent that requires sixty minutes of waiting time to have its effect, which can last up to seventy-two hours. In contrast, tropicamide requires a waiting time of forty minutes, and its effect lasts for up to 4-5 hours.  Post-cycloplegia with cyclopentolate, a child’s academic activities may be hampered for 3-4 days. Cyclopentolate has several side effects, such as nausea, problems with coordination, mental confusion, seizures, fever, and dry mouth, while tropicamide has fewer side effects.  Our study aims to compare the post-cycloplegic refractive error for the same subject on two separate visits using 1% cyclopentolate and 1% tropicamide in a two-week interval for the Eastern Indian population aged between 6 and 18 years. 
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