| CTRI Number |
CTRI/2024/11/076567 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To monitor Retinal Blood flow changes in children undergoing surgical correction of squint. |
|
Scientific Title of Study
|
Study of Macular vessel density changes using OCTA in children undergoing Strabismus surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devika Vasudevan |
| Designation |
Primary DNB Resident |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
Room 5, Ground Floor, Ophthalmology department, Pediatric Ophthalmology, Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9538359854 |
| Fax |
|
| Email |
devikavasdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Prabu V |
| Designation |
Pediatric Ophthalmologist |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
Room 5, Ground floor, Ophthalmology department, Pediatric Ophthalmology, Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9442522373 |
| Fax |
|
| Email |
rajeshprabu@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika Vasudevan |
| Designation |
Primary DNB Resident |
| Affiliation |
Sankara Eye Hospital, Coimbatore |
| Address |
Room 5, Ground floor, Ophthalmology department, Pediatric Ophthalmology, Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9538359854 |
| Fax |
|
| Email |
devikavasdev@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric Ophthalmology, Sankara Eye Hospital, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital, Coimbatore |
| Address |
16A, Sathy Road, Sivanandhapuram, Coimbatore - 641035 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Devika Vasudevan |
Sankara Eye Hospital |
Room 5 and 6, OCTA division, Pediatric Ophthalmology, 16 A, Sathy Road, Sivanandhapuram, Coimbatore - 641035
Coimbatore
TAMIL NADU |
9538359854
devikavasdev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - Sankara Eye Hospital, Coimbatore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable. |
Not Applicable. |
| Intervention |
Strabismus Correction |
Strabismus can be corrected mainly by Resection and Recession of Extraocular muscles, which will be the main focus in this study.
Other methods include Muscle transposition, Anteriorisation and Disinsertion. The Surgical intervention will be of a maximum duration of 3 hours. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 18 years
Diagnosed with Strabismus requiring surgical correction/intervention.
Children undergoing Recession/Resection procedure, Recession/Resection with Inferior Oblique Recession. |
|
| ExclusionCriteria |
| Details |
Children < 6 years and >18 years.
Children who have underwent surgical strabismus correction in the past.
Anterior segment Pathologies – Nystagmus, Corneal Opacities, Coloboma, Uveitis, Glaucoma, Cataract.
Posterior segment – Retinal/Choroidal disease like Amblyopia, Chorioretinitis, Maculopathies.
Congenital ocular diseases.
Systemic diseases like Diabetes, Hypertension, Genetic Syndromes.
Children on Systemic medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Macular vessel density changes using Swept source OCTA before & after strabismus surgery. |
Preoperative OCTA, Post Operative Day 1, Post Operative Day 15, Post Operative Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the Macular vessel density changes with the fellow eye. |
Preoperative & Post operative Day 1. |
|
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Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/12/2024 |
| 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="15" |
|
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
|
My Postgraduate Thesis is on Study of Macular vessel density changes using OCTA in children undergoing Strabismus surgery. Surgeries done to correct strabismus range from Recession/Resection procedures to Muscle Transpostions. The Extraocular muscles are supplied by Medial and Lateral Muscular Arteries which are branches of Ophthalmic Artery. The Medial muscular branch supplies the Medial rectus, Inferior rectus and Inferior oblique ; Lateral muscular branch supplies the Lateral rectus, Superior rectus and Superior oblique. The anterior segment is supplied predominantly by 7 anterior ciliary arteries arising from the muscular arteries supplying the Recti. Two each from Superior, Inferior, Medial recti and one from Lateral rectus muscle. Burden on Anteriror ciliary arteries of Medial recti to supply nasal half of anterior segment is reduced by the presence of medically placed long posterior ciliary artery. Damage to ciliary arteries are invariable during these procedures. Consequently there is compensatory collateral connections made between anterior and posterior segment circulation. The dreaded complication of Anterior segment ischemia can be avoided by refraining simultaneous surgery of 2 vertical recti and lateral rectus. Inferior oblique muscle originates from the anterior orbit medially and inserts onto the inferotemporal part of posterior sclera. The posterior end of the linear insertion lies in close proximity with the point corresponding with fovea. In Inferior oblique muscle recession there is a risk of compromising foveal vascularity leading to compensatory vascular changes post operatively. Optical coherence tomography angiography (OCTA) is a comparatively novel technique for imaging the posterior segment vasculature within a short period of time, without the use of contrast dyes (non invasive). The machine takes consecutive OCT-B scans of precise retinal cross section to produce a map of blood flow by analysing the consecutive OCT-B scans for movement of erythrocytes within retinal blood vessels. In this study we will record the vessel density in 3 segmentations of the retina, ie. Superficial Capillary Plexus (SCP), Deep Capillary Plexus (DCP), Choriocapillaris (CCP) layers both preoperatively and postoperatively among Paediatric subjects. We also intend to correlate more parameters obtained through OCTA as the study progresses. |