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

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04759560
Collaborator
(none)
133
1
13.2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    133 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biometric Characteristics Of The Eye With Microcornea/Microphthalmia And Congenital Cataract Before And After Cataract Extraction
    Actual Study Start Date :
    Jul 25, 2020
    Anticipated Primary Completion Date :
    Jul 25, 2021
    Anticipated Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative changes in the biometric characteristics of eyes at 3months [3 months]

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

    2. Postoperative changes in the biometric characteristics of eyes at 6months [6 months]

      the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy

    Secondary Outcome Measures

    1. Postoperative complications at 3 months [3 months]

      we will report occurence of postoperative complications

    2. Postoperative complications at 6months [6 months]

      we will report occurence of postoperative complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medecine Alexandria Alexandria/ Egypt Egypt 21111

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    • Principal Investigator: Gloria Nshokano Simba, MBBch, Alexandria University
    • Study Director: Nader L Bayoumi, Professor, Alexandria University
    • Study Chair: Nihal Mohamed Elshakankiri, Professor, Alexandria University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nshokano Simba Gloria, Ophthalmology resident, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT04759560
    Other Study ID Numbers:
    • MICROCORNEA/MICROPHTHALMIA
    First Posted:
    Feb 18, 2021
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nshokano Simba Gloria, Ophthalmology resident, Alexandria University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2021