An Interocular Comparative Study of Unilateral Cataract

Overview

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.

Full Title of Study: “Interocular Anatomical and Visual Functional Differences in Pediatric Patients With Unilateral Cataracts at 3 Months Post-surgery: A Cross-sectional Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: January 2016

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.

Clinical Trial Outcome Measures

Primary Measures

  • Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam
    • Time Frame: 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
    • Time Frame: Baseline
    • The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Ministry of Health, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Haotian Lin, Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center – Sun Yat-sen University
  • Overall Official(s)
    • Haotian Lin, M.D., Ph.D, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Yizhi Liu, M.D., Ph.D, Study Chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Weirong Chen, M.D., Study Director, Zhongshan Ophthalmic Center, Sun Yat-sen University

References

Hutcheson KA. Application of new ophthalmic technology in the pediatric patient. Curr Opin Ophthalmol. 2007 Sep;18(5):384-91. doi: 10.1097/ICU.0b013e328244e07e.

Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.

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