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Congenital CataractNCT04759560

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

An observational study of Congenital Cataract and Microphthalmos, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 3 months to 7 years
Conditions the study is for
Congenital Cataract, Microphthalmos, Microcornea
How many people
133 participants
Where
1 siteEgypt
Study dates
25 Jul 2020to 1 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 7 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Gloria Nshokano Simba, MBBch contact

01123645112

nshokanosim90@gmail.com

nader L Bayoumi, Professor contact

01005268758

naderayoumi@yahoo.com

Egypt1 site, 1 recruiting

  • Faculty of Medecine

    Alexandria, Alexandria/ Egypt, 21111

    Gloria Nshokano Simba, MBBCh, 01123645112, nshokanosim90@gmail.com

    Nader L Bayoumi, Professor, 01005268758, naderayoumi@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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

Keywords
anterior segment biometry, cataract surgery, aphakia/ pseudophakia
Medical subject headings
Microphthalmos

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy

    biomicroscopy

    Measured: 3 months

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

    the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy

    Measured: 6 months

Secondary outcomes (2)

  1. Postoperative complications at 3 months

    we will report occurence of postoperative complications

    Measured: 3 months

  2. Postoperative complications at 6months

    we will report occurence of postoperative complications

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start25 Jul 2020
  3. Primary completion25 Jul 2021 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04759560
Sponsor's protocol ID
MICROCORNEA/MICROPHTHALMIA
Status last verified
Feb 2021
First submitted
15 Feb 2021
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26603400

  • 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.

    PubMed 24061837

  • 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.

    PubMed 27334676

  • 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.

    PubMed 28220849

  • 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.

    PubMed 25592478

  • 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.

    PubMed 19781495

  • 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.

    PubMed 19251147

  • 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.

    PubMed 21140367

  • 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.

    PubMed 17533105

  • 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.

    PubMed 19004499

  • 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.

    PubMed 30559816

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Cataract and Microphthalmos, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gloria Nshokano Simba, MBBch (01123645112, nshokanosim90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative changes in the biometric characteristics of eyes at 3months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04759560, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.

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