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Clinical Trials/NCT04759560
NCT04759560
Unknown
Not Applicable

Biometric Characteristics Of The Eye With Microcornea/Microphthalmia And Congenital Cataract Before And After Cataract Extraction

Alexandria University1 site in 1 country133 target enrollmentJuly 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Cataract
Sponsor
Alexandria University
Enrollment
133
Locations
1
Primary Endpoint
Postoperative changes in the biometric characteristics of eyes at 6months
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 25, 2020
End Date
September 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nshokano Simba Gloria

Ophthalmology resident

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • 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).
  • 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

Outcomes

Primary Outcomes

Postoperative changes in the biometric characteristics of eyes at 6months

Time Frame: 6 months

the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy

Postoperative changes in the biometric characteristics of eyes at 3months

Time Frame: 3 months

the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy biomicroscopy

Secondary Outcomes

  • Postoperative complications at 3 months(3 months)
  • Postoperative complications at 6months(6 months)

Study Sites (1)

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