Vascular changes seen on retinal imagining test (optical coherence tomography angiography) before and after occlusion therapy in amblyopia.

Not yet recruiting

• Conditions: Visual disturbances,

• Registration Number: CTRI/2023/08/056388
• Lead Sponsor: Maulana Azad Medical College and Associated Hospitals

Brief Summary

WE WILL BE EVALUATING THE MICROVASCULAR PARAMETERS BEFORE AND AFTER AMBLYOPIA PATCHING THERAPY IN CHILDREN AGED 4 TO 12 YEARS ATTENDING THE PEDIATRIC OPHTHALMOLOGY CLINIC (POC) AT GURU NANAK EYE CENTRE. A TOTAL OF 15 CHILDREN WITH UNILATERAL AMBLYOPIA WILL BE RECRUITED WHO WILL BE GIVEN PATCHING THERAPY ACCORDING TO THEIR AGES AND MICROVASCULAR PARAMETERS WILL BE RECORDED AND COMPARED BEFORE AND AFTER THE THERAPY THROUGH OPITICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY(OCTA).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-08
• Study Start: 2023-08-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 1.Patients aged 4-12 years.
• 2.Patients with strabismic / anisometropic /sensory deprivation amblyopia.
• 3.Pseudophakic patients with clear visual axis.

Exclusion Criteria

• 1.Bilateral amblyopia 2.Ametropic amblyopia 3.Poor quality OCT-A scans 4.Poor fixation/ nystagmus/ uncooperative children 5.Children with spherical refractive errors of +/-5.00 diopters(D) or cylindrical refractive errors of 3.00 diopters(D) or greater.
• 6.Ocular diseases viz.
• corneal opacities, uveitis, retinal pathology.
• 7.History of prematurity.
• 8.History of neurological disease.
• 9.History of any systemic condition that could alter the retinal microvasculature (juvenile onset diabetes, renal disease, hypertension).
• 10.History of skin allergies and irritations with bandage-type occluders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T0 assess the retinal microvasculature in pre-treatment & post-treatment amblyopic eyes using following parameters in OCTA [Model: RS-3000 LITE advanced (NIDEK)]:	3 MONTHS
•Macular Vessel density percentage of SCP scan	3 MONTHS
•Foveal Avascular Zone Measurements (FAZ) (mm2)	3 MONTHS
•Macular Vessel density percentage of DCP scan	3 MONTHS

Secondary Outcome Measures

Name	Time	Method
To assess the following parameters in pre-treatment & post-treatment amblyopic eyes using OCT (Model: REVO 60 Optipol)	•Central Macular thickness (µm)

Trial Locations

Locations (1)

Guru Nanak Eye Centre; 🇮🇳 Central, DELHI, India

Guru Nanak Eye Centre

🇮🇳Central, DELHI, India

Dr Meghna Sethi

Principal investigator

9560601175

meghnasethi25@gmail.com