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

NCT ID: NCT04759560

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-25

Study Completion Date

2021-09-01

Brief Summary

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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

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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

Conditions

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Congenital Cataract Microphthalmos Microcornea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Nshokano Simba Gloria

Ophthalmology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gloria Nshokano Simba, MBBch

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Nader L Bayoumi, Professor

Role: STUDY_DIRECTOR

Alexandria University

Nihal Mohamed Elshakankiri, Professor

Role: STUDY_CHAIR

Alexandria University

Locations

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Faculty of Medecine

Alexandria, Alexandria/ Egypt, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Gloria Nshokano Simba, MBBch

Role: CONTACT

01123645112

nader L Bayoumi, Professor

Role: CONTACT

01005268758

Facility Contacts

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Gloria Nshokano Simba, MBBCh

Role: primary

01123645112

Nader L Bayoumi, Professor

Role: backup

01005268758

References

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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.

Reference Type BACKGROUND
PMID: 19251147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21140367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17533105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26603400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24061837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27334676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28220849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25592478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19781495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19004499 (View on PubMed)

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.

Reference Type RESULT
PMID: 30559816 (View on PubMed)

Other Identifiers

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MICROCORNEA/MICROPHTHALMIA

Identifier Type: -

Identifier Source: org_study_id

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