Clinical trial NCT02765230: An Interocular Comparative Study of Unilateral Cataract
Official title: Interocular Anatomical and Visual Functional Differences in Pediatric Patients With Unilateral Cataracts at 3 Months Post-surgery: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2016-05-06
Enrollment: 53
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All of the registered children of CCPMOH were diagnosed by anterior segmental photography to confirm the morphology, location, and degree of cataract after pupil dilation. Fifty-three pediatric patients (53 cataract eyes and 53 contralateral normal eyes) with uncomplicated unilateral total cataract were selected 3 months after surgery from the CCPMOH.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam
timeFrame: Baseline
measure: Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., Ph.D
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.