A clinical trial to study the comparison of hydrophilic intraocular lens and silicone lens in children undergoing cataract surgery

• Conditions: Pediatric cataract

• Registration Number: CTRI/2010/091/000195
• Lead Sponsor: Dr Jagat Ram

Brief Summary

This prospective clinical study was conducted among children (age 1month to 8 years) with congenital/developmental cataract in a tertiary care centre. The children were randomly divided into two groups. All participants underwent phacoaspiration, primary posterior capsulotomy and anterior vitrectomy. Group A (n=21) was implanted with acrylic hydrophobic, AcrySof SA60AT® intra ocular lens (IOL), where as Group B (n=20) was implanted with silicone, Tecnis Z9000® IOL. The children were evaluated for anterior chamber reaction, IOL position, posterior capsular opacification (PCO), intraocular pressure (IOP), best corrected visual acuity (BCVA), corneal status and refractive errors.Postoperatively, two eyes in each group had significant anterior chamber reaction with fibrin membrane formation. Cornea was clear in both groups. IOLs were in the capsular bag in all but one eye in both groups. Seven eyes in the acrylic group and six eyes in the silicone group achieved visual acuity of 20/40 or better. None of the eye had glaucoma. Best corrected visual acuity (BCVA) at one year was similar in both groups. In the acrylic hydrophobic group, 14 eyes needed hypermetropic correction and 7 eyes were myopic where as in the silicone group 10 eyes had myopia and 10 eyes had hypermetropia at 1 year postoperatively. Posterior capsule opacification at one year postoperative was more common in eyes implanted with acrylic hydrophobic IOL (5 eyes) than in silicone IOL (2 eyes).

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 41

Inclusion Criteria

• (a) Children, aged one month to eight years, with visually significant congenital or developmental cataract.
• (b) Partial or dense, visually significant cataract, involving 3 mm or more of the central visual axis.

Exclusion Criteria

• (a) Presence of an associated ocular disease such as microphthalmia, microcornea, glaucoma, uveitis, complicated cataract, posterior lenticonus, coloboma, subluxated lens, retinal lesions like retinal detachment, retinal holes etc.
• (b) Suspected pre existing posterior capsular defects like traumatic cataract (c) Systemic diseases (d) Children in whom the axial length of the eye < 17mm.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual axis opacification (VAO), PCO, membranectomy rates for significant VAO	one year

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Jagat ram

Principal investigator

01722756111

drjagatram@yahoo.com