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CTRI Number  CTRI/2020/09/028092 [Registered on: 28/09/2020] Trial Registered Prospectively
Last Modified On: 28/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Occlusion therapy]  
Study Design  Other 
Public Title of Study   Study of thickness of blood supply layer within the eye in children with one eye being lazy using scan machine , before and after treatment for lazy eye. 
Scientific Title of Study   Analysis of Choroidal thickness in children with unilateral amblyopia using swept source optical coherence tomography and their changes following occlusion therapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrutika Baburao Bhimewar 
Designation  Resident (DNB) Ophthalmology 
Affiliation  Sankara Eye Hospital, Shimoga 
Address  Room no. 23, Department of paediatric ophthalmology, Sankara Eye Hospital, Harakere, Tirthahalli road

Shimoga
KARNATAKA
577202
India 
Phone  8275940851  
Fax    
Email  sbb239@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavitha V 
Designation  Senior consultant, Paediatric Ophthalmology  
Affiliation  Sankara Eye Hospital, Shimoga 
Address  Room no. 23, Department of paediatric ophthalmology,Sankara Eye Hospital, Harakere, Tirthahalli road

Shimoga
KARNATAKA
577202
India 
Phone  9663329877  
Fax    
Email  kavithachalam2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shrutika Baburao Bhimewar 
Designation  Resident (DNB) Ophthalmology 
Affiliation  Sankara Eye Hospital, Shimoga 
Address  Room no. 23, Department of paediatric ophthalmology, Sankara Eye Hospital, Harakere, Tirthahalli road

Shimoga
KARNATAKA
577202
India 
Phone  8275940851  
Fax    
Email  sbb239@gmil.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital,Harakere, Tirthahalli road, Shimoga,Karnataka-577202 
 
Primary Sponsor  
Name  Sankara Eye Hospital Shimoga 
Address  Harakere, Tirthahalli road, Shimoga. 
Type of Sponsor  Research institution and hospital 
 
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 Shrutika Baburao Bhimewar   Sankara Eye Hospital  Room no. 23, Department of paediatric ophthalmology, Harakere, Tirthahalli road
Shimoga
KARNATAKA 		 8275940851

sbb239@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Sankara Eye Hospital, Shimoga.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H530||Amblyopia ex anopsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Spectacles and Occlusion therapy  At first visit, Spectacles will be given. One month after 1st visit (Post- spectacle wear), the normal fellow eye in amblyopic patients will be patched for 4-6 hrs. per day. 
Comparator Agent  Swept source optical coherence tomography  Choroidal thickness, macular thickness, peripapillary retinal nerve fibre layer thickness and macular vascular density will be measured at each follow up visit of 3rd month,6th month and 12th month and compared with normal fellow eye and normal eyes of normal children. 
Comparator Agent  Swept source optical coherence tomography  Choroidal thickness, macular thickness, peripapillary retinal nerve fibre layer thickness and macular vascular density will be measured at first visit and compared with normal fellow eye and normal eyes of normal children. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children with unilateral strabismic and anisometropic amblyopia will be included in group 1.
2. Uncorrected visual acuity of LogMAR 0.00 in both eyes will be included in group 2.
3. Children with normal neurological, ocular and systemic examination.
4. Children who will be willing for follow up.  
 
ExclusionCriteria 
Details  1.Previous history of Spectacle wear/ Occlusion therapy/ Ocular surgery.
2.Refractive error correction >6D Spherical power and >3D Cylindrical power.
3. Presence of Nystagmus/ Hearing impairment/ Development delay.
4. Not compliant for Spectacle wear and/ or occlusion therapy.
5. Children who will have poor fixation co-operation for SS-OCT test due to poor vision or lower age.
6. Children who will come for <2 follow up. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Analysis of Choroidal thickness changes in children with unilateral amlyopia   at presentation(baseline) and on follow up visits of 3rd, 6th and 12th month. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Analysis of macular thickness, peripapillary retinal nerve fibre layer thickness and macular vascular density changes in children with unilateral amblyopia .  On presentation (baseline) and follow up visits of 3rd, 6th and 12th month. 
2. Study of occlusion therapy on the choroidal thickness, macular thickness, peripapillary retinal nerve fibre layer thickness and macular vascular density.  On follow up visits of 3rd, 6th and 12th month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/10/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Amblyopia is defined as decrease of visual acuity in one eye when caused by abnormal binocular interaction or occurring in one or both eyes as a result of pattern vision deprivation during visual immaturity, for which no cause can be detected during the physical examination of the eye (s) and which in appropriate cases is reversible by therapeutic measures.
Choroid is the posterior most part of the uveal tissue and has maximum vascular supply per unit mass in the eye.
Optical Coherence Tomography (OCT) is non-invasive technique allowing high resolution, cross sectional tomographic images of choroid, retina, optic nerve and its layers. 
It is based on low coherence interferometry typically employing near infrared light.
OCT measures choroidal thickness (CT), macular thickness(MT), peripapillary retinal nerve fibre layer thickness (RNFLT). Macular vascular density (MVD) is measured by OCT Angiography
(OCTA).    
Occlusion therapy has long been the mainstay of amblyopia treatment.
Various studies are available documenting changes in choroidal thickness (CT), macular thickness (MT), foveal thickness(FT) and retinal nerve fibre thickness (RNFLT) in amblyopic eyes.
However, there are only few studies available on analysis of these parameters following occlusion therapy.
Hence, the purpose of our study is not only to analyse structural changes in choroidal , macular , peripapillary RNFLT and macular vascular density  in unilateral amblyopic eyes and compare the same
with normal fellow eye and normal eyes of normal children but also to understand the same following occlusion therapy.

 
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