An Interocular Comparative Study of Unilateral Cataract

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765230
• Other study ID #: CCPMOH2016-China-3
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: May 5, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Hutcheson KA. Application of new ophthalmic technology in the pediatric patient. Curr Opin Ophthalmol. 2007 Sep;18(5):384-91. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam	The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera.	Baseline	No
Primary	Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards	The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).	Baseline	No

External Links

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