NCT04759560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 15, 2021

Last Update Submit

February 17, 2021

Conditions

Congenital CataractMicrophthalmosMicrocornea

Keywords

anterior segment biometrycataract surgeryaphakia/ pseudophakia

Outcome Measures

Primary Outcomes (2)

  • Postoperative changes in the biometric characteristics of eyes at 3months

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

    3 months

  • Postoperative changes in the biometric characteristics of eyes at 6months

    the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy

    6 months

Secondary Outcomes (2)

  • Postoperative complications at 3 months

    3 months

  • Postoperative complications at 6months

    6 months

Eligibility Criteria

Age3 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medecine

Alexandria, Alexandria/ Egypt, 21111, Egypt

RECRUITING

Related Publications (11)

  • Praveen MR, Vasavada AR, Shah SK, Khamar MB, Trivedi RH. Long-term postoperative outcomes after bilateral congenital cataract surgery in eyes with microphthalmos. J Cataract Refract Surg. 2015 Sep;41(9):1910-8. doi: 10.1016/j.jcrs.2015.10.005.

    PMID: 26603400BACKGROUND

  • Ventura MC, Sampaio VV, Ventura BV, Ventura LO, Nose W. Congenital cataract surgery with intraocular lens implantation in microphthalmic eyes: visual outcomes and complications. Arq Bras Oftalmol. 2013 Jul-Aug;76(4):240-3. doi: 10.1590/s0004-27492013000400011.

    PMID: 24061837BACKGROUND

  • Wu X, Long E, Lin H, Liu Y. Prevalence and epidemiological characteristics of congenital cataract: a systematic review and meta-analysis. Sci Rep. 2016 Jun 23;6:28564. doi: 10.1038/srep28564.

    PMID: 27334676BACKGROUND

  • Chen D, Gong XH, Xie H, Zhu XN, Li J, Zhao YE. The long-term anterior segment configuration after pediatric cataract surgery and the association with secondary glaucoma. Sci Rep. 2017 Feb 21;7:43015. doi: 10.1038/srep43015.

    PMID: 28220849BACKGROUND

  • Prasad S, Ram J, Sukhija J, Pandav SS, Gupta PC. Cataract surgery in infants with microphthalmos. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):739-43. doi: 10.1007/s00417-014-2908-8. Epub 2015 Jan 16.

    PMID: 25592478BACKGROUND

  • Khokhar SK, Dave V. Cataract surgery in infant eyes with microphthalmos. J Cataract Refract Surg. 2009 Oct;35(10):1844; author reply 1844-5. doi: 10.1016/j.jcrs.2009.05.040. No abstract available.

    PMID: 19781495BACKGROUND

  • 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.

    PMID: 19251147BACKGROUND

  • 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.

    PMID: 21140367BACKGROUND

  • Nishina S, Noda E, Azuma N. Outcome of early surgery for bilateral congenital cataracts in eyes with microcornea. Am J Ophthalmol. 2007 Aug;144(2):276-280. doi: 10.1016/j.ajo.2007.04.019. Epub 2007 May 29.

    PMID: 17533105BACKGROUND

  • 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.

    PMID: 19004499BACKGROUND

  • Majid S, Ateeq A, Bukari S, Hussain M. Outcomes of cataract surgery in Microophthalmia. Pak J Med Sci. 2018 Nov-Dec;34(6):1525-1528. doi: 10.12669/pjms.346.14622.

    PMID: 30559816RESULT

MeSH Terms

Conditions

Microphthalmos

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gloria Nshokano Simba, MBBch

    Alexandria University

    PRINCIPAL INVESTIGATOR

  • Nader L Bayoumi, Professor

    Alexandria University

    STUDY DIRECTOR

  • Nihal Mohamed Elshakankiri, Professor

    Alexandria University

    STUDY CHAIR

Central Study Contacts

Gloria Nshokano Simba, MBBch

CONTACT

01123645112nshokanosim90@gmail.com

nader L Bayoumi, Professor

CONTACT

01005268758naderayoumi@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology resident

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 18, 2021

Study Start

July 25, 2020

Primary Completion

July 25, 2021

Study Completion

September 1, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)