Clinical trial NCT04759560: Biometric Characteristics of the Eye With Microcornea/Microphthalmia and Congenital Cataract Before And After Cataract Extraction
Official title: Biometric Characteristics Of The Eye With Microcornea/Microphthalmia And Congenital Cataract Before And After Cataract Extraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Cataract
Microphthalmos
Microcornea
Keywords: anterior segment biometry
cataract surgery
aphakia/ pseudophakia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 133
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children between 3months and 7 years with congenital cataract without other ocular anomalies other than micornea/ microphthalmia; who will visit the pediatric ophthalmology clinic of Alexandria main University from july 2020 to january 2021.

Brief summary: Early cataract surgery in microcornea/microphthalmia eyes is essential to prevent amblyopia and improve visual outcomes, including stereopsis. However, despite recent advances in pediatric cataract microsurgical techniques, this surgery remains challenging owing to several intraoperative difficulties attributable to the crowded anterior segment in these small, soft, and poorly developed eyes with shallow anterior chambers, and poor pupillary dilation.

In this study the investigator aim to report on the changes in the anterior segment biometric characteristics after cataract extraction in eyes with microcornea/microphthalmia with congenital cataract.

Detailed description: Eyes with congenital cataract have usually small cornea due to developmental delay of the globe. Recognition of microcornea/microphthalmia may be important as a potential contributor to the development of aphakic glaucoma after cataract surgery. Biometrics characteristics of eyes with m/m before and after removal of the cataractous lens can justify the occurrence of postoperative complications, including glaucoma.

Aim of the study: to report on the changes in the anterior segment biometric characteristics after cataract extraction in eyes with microcornea/microphthalmia with congenital cataract.

Methods:

The study will be a prospective cohorte. Biometry of eligible eyes with congenital cataract in one or both eyes with horizontal cornea diameter less than 11mm and/or axial length less than 2standard deviation for age will be compare to otherwise normal eyes with congenital cataract before and after cataract extraction. The anterior segment biometric characteristics using ultrasound biomicroscopy to measure anterior chamber depth and angle.Cataract surgery will be conducted with or without intraocular lens implantation.Postoperative follow up will be scheduled at the first week and first month, third and sixth months

Eligibility criteria: Inclusion Criteria:

1. Children presenting with congenital cataract in one or both eyes and with a horizontal corneal diameter less than 11 mm and/or an axial length less than 2 standard deviations for age of the child, less than 18mm in children under one year and less than 20mm in those less than 1year (cases).
2. Children presenting with congenital cataract in one or both eyes with otherwise normal ocular biometric characteristics (controls).

Exclusion Criteria:

1.Children presenting with congenital cataract associated with other ocular anomalies other than microcornea/microphthalmia

Primary outcomes:
measure: Postoperative changes in the biometric characteristics of eyes at 3months
timeFrame: 3 months
measure: Postoperative changes in the biometric characteristics of eyes at 6months
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative complications at 3 months
timeFrame: 3 months
measure: Postoperative complications at 6months
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medecine
state: Alexandria/ Egypt
Study officials:
affiliation: Alexandria University
name: Gloria Nshokano Simba, MBBch
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Nader L Bayoumi, Professor
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Nihal Mohamed Elshakankiri, Professor
role: STUDY_CHAIR
References:
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citation: Vasavada VA, Dixit NV, Ravat FA, Praveen MR, Shah SK, Vasavada V, Vasavada AR, Trivedi RH. Intraoperative performance and postoperative outcomes of cataract surgery in infant eyes with microphthalmos. J Cataract Refract Surg. 2009 Mar;35(3):519-28. doi: 10.1016/j.jcrs.2008.11.031.
citation: Filous A, Osmera J, Hlozanek M, Mahelkova G. Central corneal thickness in microphthalmic eyes with or without history of congenital cataract surgery. Eur J Ophthalmol. 2011 Jul-Aug;21(4):374-8. doi: 10.5301/EJO.2010.6090.
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citation: Abouzeid H, Meire FM, Osman I, ElShakankiri N, Bolay S, Munier FL, Schorderet DF. A new locus for congenital cataract, microcornea, microphthalmia, and atypical iris coloboma maps to chromosome 2. Ophthalmology. 2009 Jan;116(1):154-162.e1. doi: 10.1016/j.ophtha.2008.08.044. Epub 2008 Nov 12.
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