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

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759560
• Other study ID #: MICROCORNEA/MICROPHTHALMIA
• Status: Recruiting
• Start date: July 25, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2021
• Source: Alexandria University
• Contact: Gloria Nshokano Simba, MBBch
• Phone: 01123645112
• Email: nshokanosim90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: September 1, 2021
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Congenital Cataract
• Microcornea
• Microphthalmos

Locations

Country	Name	City	State
Egypt	Faculty of Medecine	Alexandria	Alexandria/ Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ventura MC, Sampaio VV, Ventura BV, Ventura LO, Nosé 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. — View Citation

Wu X, Long E, Lin H, Liu Y. Prevalence and epidemiological characteristics of congenital cataract: A systematic review and meta-analysis. Sci Rep [Internet]. 2016;6(October 2015):1-10. Available from: http://dx.doi.org/10.1038/srep28564

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative changes in the biometric characteristics of eyes at 3months	the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy; biomicroscopy	3 months
Primary	Postoperative changes in the biometric characteristics of eyes at 6months	the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy	6 months
Secondary	Postoperative complications at 3 months	we will report occurence of postoperative complications	3 months
Secondary	Postoperative complications at 6months	we will report occurence of postoperative complications	6 months