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Comparison of two intra-ocular lenses in developmental cataract in children

A Study to Compare Visual Outcomes of Enhanced Monofocal IOLs vs Monofocal IOLs in the Pediatric Age Group - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096440
Enrollment
40
Registered
2025-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H260- Infantile and juvenile cataract

Interventions

Intervention1: Cataract extraction plus enhanced monofocal intraocular lens implantation under general anaesthesia (Group A): All cases of bilateral developmental cataract will be assessed, and based

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral developmental cataract with lens opacity obscuring red reflex and visual acuity less than 20/40 (0.3 logMAR) Axial Length between 21-25 mm Keratometry between 41-46D with no signs of ectasia Horizontal WTW between 10.5-12 mm Parents willing to enroll in the study and follow up

Exclusion criteria

Exclusion criteria: Near VA better than N8 (0.4 logMAR) Presence of concomittant ocular pathogies like allergic conjunctivitis, nystagmus, microcornea, corneal ectasia, keratitis, corneal opacities, total cataract,partially absorbed cataract, microspherophakia, lens subluxation or dislocation, glaucoma, optic atrophy, uveitis and retinal detachment. Cases with history of trauma. Systemic disorders like intellectual disability, congenital rubella syndrome and Down’s syndrome. Parents unwilling to enroll in study and follow up

Design outcomes

Primary

MeasureTime frame
Percentage of children achieving binocular Unaided Near Vision N8 (0.4 logMAR) or betterTimepoint: 1 month, 6 month, 12 months after intervention

Secondary

MeasureTime frame
Comparison of visual outcomes in both groups with respect to post operative UDVA, CDVA, UIVA and CIVA at 66cm, Subjection Refraction and Acceptance, Percentage of eyes with 0.5D of Target, Stereopsis, Contrast Sensitivity, Internal Higher Order Aberrations, Need for Near Aid Timepoint: 1 month, 6 month, 12 months after intervention

Countries

India

Contacts

Public ContactDr Tushar Agarwal

All India Institute of Medical Sciences

drtushar@gmail.com01126593050

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026