Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

Completed

• Conditions: Microphthalmos With Congenital Cataracts
• Interventions: Procedure: Cataract surgery

• Registration Number: NCT01818037
• Lead Sponsor: Iladevi Cataract and IOL Research Center

Brief Summary

Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.

In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery.

In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes.

Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-25
• Last Update Submitted: 2013-03-25
• Study First Posted: 2013-03-26
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Presence of microphthalmos and congenital cataract.
• Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes

Exclusion Criteria

• Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Microphthalmos with congenital cataract	Cataract surgery	72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.

Primary Outcome Measures

Name	Time	Method
Glaucoma following cataract surgery	45 months postoperative

Secondary Outcome Measures

Name	Time	Method
Posterior synechiae	45 months postoperatively
visual axis obscuration	45 months
axial length rate of growth	45 months postoperatively
central corneal thickness	45 months postoperatively
visual acuity	45 months postoperatively

Trial Locations

Locations (1)

Iladevi Cataract & IOL Research Center; 🇮🇳 Ahmedabad, Gujarat, India