An Interocular Comparative Study of Unilateral Cataract

NCT ID: NCT02765230

Last Updated: 2016-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Cataract

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haotian Lin, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Yizhi Liu, M.D., Ph.D

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Weirong Chen, M.D.

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 17700231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22921386 (View on PubMed)

Long E, Chen J, Liu Z, Lin Z, Cao Q, Zhang X, Li X, Luo L, Lin H, Chen W, Liu Y. Interocular anatomical and visual functional differences in pediatric patients with unilateral cataracts. BMC Ophthalmol. 2016 Nov 3;16(1):192. doi: 10.1186/s12886-016-0371-5.

Reference Type DERIVED
PMID: 27809833 (View on PubMed)

Related Links

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http://www.gzzoc.com/

Description Home page of Zhongshan Ophthalmic Center

Other Identifiers

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CCPMOH2016-China-3

Identifier Type: -

Identifier Source: org_study_id

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