An Interocular Comparative Study of Unilateral Cataract

Completed

• Conditions: Cataract

• Registration Number: NCT02765230
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Detailed Description

Great advances have been made in managing pediatric cataracts during the last several decades; these advances have contributed to a decrease in the incidence of postoperative complications and improvement in visual outcomes.Early cataract removal and replacement with an intraocular lens (IOL) represent the most appropriate treatments to avoid irreversible amblyopia.Although screening and timely surgical intervention play a key role in improved best corrected visual acuity (BCVA) among pediatric patients with cataracts, determining the prognosis for an individual remains difficult, particularly for unilateral cataract.

Few studies have focused on the interocular differences in ocular anatomic parameters other than axial length in unilateral pediatric cataract after surgery, the significance of which for the possible interocular visual functional difference remains unclear. Therefore, the investigators conducted this cross-sectional study to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Children with uncomplicated surgeries
• Children who were younger than 10 years old
• Children with unilateral total cataract

Exclusion Criteria

• Premature birth
• Microphthalmia
• Micro-or Megalocornea
• Keratoconus
• Glaucoma
• Traumatic or complicated cataracts
• Vitreous and retinal diseases
• Any previous surgeries

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam	Baseline	The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera.
Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards	Baseline	The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China