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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Microphthalmos; Congenital Cataract; Microcornea

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 Type: Observational
• Enrollment (Anticipated): 133

Contacts and Locations

• Study Contact: Name: Gloria Nshokano Simba, MBBCh; Phone Number: 01123645112; Email: nshokanosim90@gmail.com
• Study Contact Backup: Name: Nader L Bayoumi, Professor; Phone Number: 01005268758; Email: naderayoumi@yahoo.com

Study Locations

• Egypt
  • Alexandria/ Egypt
    • Alexandria, Alexandria/ Egypt, Egypt, 21111
      • Recruiting
      • Faculty of medecine
      • Contact: Gloria Nshokano Simba, MBBCh; Phone Number: 01123645112; Email: nshokanosim90@gmail.com
      • Contact: Nader L Bayoumi, Professor; Phone Number: 01005268758; Email: naderayoumi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications at 3 months	we will report occurence of postoperative complications	3 months
Postoperative complications at 6months	we will report occurence of postoperative complications	6 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Epub 2007 May 29.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Anticipated): July 25, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cataract surgery; anterior segment biometry; aphakia/ pseudophakia
• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eye Abnormalities; Lens Diseases; Cataract; Capsule Opacification; Microphthalmos
• Other Study ID Numbers: MICROCORNEA/MICROPHTHALMIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No