Biometric Characteristics of the Eye With Microcornea/Microphthalmia and Congenital Cataract Before And After Cataract Extraction

• Conditions: Microphthalmos; Microcornea; Congenital Cataract

• Registration Number: NCT04759560
• Lead Sponsor: Alexandria University

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

Study Timeline

• Study Start: 2020-07-25
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-07-25
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative changes in the biometric characteristics of eyes at 6months	6 months	the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy
Postoperative changes in the biometric characteristics of eyes at 3months	3 months	the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy; biomicroscopy

Secondary Outcome Measures

Name	Time	Method
Postoperative complications at 3 months	3 months	we will report occurence of postoperative complications
Postoperative complications at 6months	6 months	we will report occurence of postoperative complications

Trial Locations

Locations (1)

Faculty of Medecine; 🇪🇬 Alexandria, Alexandria/ Egypt, Egypt