| CTRI Number |
CTRI/2024/03/064786 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Progression of myopia or short sightedness in children following surgery for intermittent exotropia which is characterized by occasional outward deviation of one or both eyes. |
|
Scientific Title of Study
|
A Prospective study of Myopia Progression in Children following surgical intervention for Intermittent exotropia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purva Kavishwar |
| Designation |
Primary DNB resident |
| Affiliation |
Aravind Eye Hospital, Chennai |
| Address |
Aravind Eye Hospital, Poonamallee high road, opposite Saveetha dental college, Noombal, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9821426147 |
| Fax |
|
| Email |
kavishwar.purva@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Bisani |
| Designation |
Medical consultant |
| Affiliation |
Aravind Eye Hospital, Chennai |
| Address |
Aravind Eye Hospital, Poonamallee high road, opposite Saveetha dental college, Noombal, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9840450042 |
| Fax |
|
| Email |
ankita.bisani@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Bisani |
| Designation |
Medical consultant |
| Affiliation |
Aravind Eye Hospital, Chennai |
| Address |
Aravind Eye Hospital, Poonamallee high road, opposite Saveetha dental college, Noombal, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9840450042 |
| Fax |
|
| Email |
ankita.bisani@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Poonamallee high road, opposite Saveetha dental college, Noombal, Chennai- 600077, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Purva Kavishwar |
| Address |
Aravind Eye Hospital, Poonamallee high road, opposite Saveetha dental college, Noombal, Chennai |
| 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 |
| Purva Kavishwar |
Aravind Eye Hospital |
Room No. 201, Department of Pediatric Ophthalmology and Strabismus, Aravind Eye Hospital, Poonamallee high road, opposite Saveetha dental college, Noombal, Chennai- 600077
Chennai
TAMIL NADU |
9821426147
kavishwar.purva@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H503||Intermittent heterotropia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who underwent surgery for IXT and achieved correction within plus/minus 10 prism diopters at 2 weeks post operatively.
2.Patients with myopia minus 0.5D to minus 6D
3.Astigmatism less than 2D
4.Anisometropia less than 2D
5.Amblyopia with BCVA more than 6/12
|
|
| ExclusionCriteria |
| Details |
1.Patients with high myopia more than minus 6D
2.Lenticular myopia
3.K reading less than 36D or more than 48D
4.Previous ocular surgeries
5.Previous treatment with atropine or myopia control spectacle lenses or ortho K contact lenses
6.Retinopathy of prematurity/ congenital anomaly / glaucoma/retinal pathology
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of myopia progression in patients who underwent surgical intervention for intermittent exotropia |
At baseline, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze whether age of surgery for intermittent exotropia influences myopia progression |
18 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to prospectively study myopia progression in children who underwent surgical intervention for intermittent exotropia. Role of myopia in intermittent exotropia is reportedly due to increased accommodative demand caused by the exodeviation. The patients aged 5-15 years who fulfil the inclusion/exclusion criteria will be enrolled for the study and thoroughly counselled. At 2 weeks post- operatively, A scan biometry will be done for every patient to measure the axial length. A questionnaire will be handed over to the parents which includes questions related to risk factors associated with myopia progression. Patients will be followed up on 6 months and 12 months and they will undergo visual acuity testing, cycloplegic refraction with 3m Snellen’s chart, intraocular pressure measurement, anterior and posterior segment evaluation and A scan biometry to measure axial length (LENSTAR). Myopia progression will be analyzed and documented in terms of spherical equivalent and axial length. |