Modified Surgical Techniques for Pediatric Cataract Treatment

NCT01844258 | Completed DMC

• 1 other identifier: CCPMOH2010-China3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric cataract is totally different from adult cataract. There is traditionally no difference in technique between pediatric and adult cataract surgery. Opacification of the visual axis was the most frequent complication after pediatric surgery. In this clinical study, the investigators aimed to evaluate the safety and postoperative recovery of a modified technique for pediatric cataract surgery.

Conditions

Cataract

Keywords

pediatric cataract; lens regeneration; endogenous lens epithelial stem cells; visual axis opacification; visual function

Outcome Measures

Primary Outcomes (1)

• Incidence of opacification of the visual axis

  six months

Secondary Outcomes (1)

• Visual function in eyes treated for cataract

  6 months

Other Outcomes (1)

• Postoperative complications

  6 months

Study Arms (2)

Modified technique for I/A group

EXPERIMENTAL

* In the modified cataract surgery procedure, the size of the capsulorhexis opening will be decreased to 1.0-1.5 mm in diameter. * The capsulorhexis will be located in the peripheral area of the lens instead of the central area. * A 0.9 mm phacoemulsification probe will be used to remove the cataractous lens. * One drop of 0.5% or 1% atropine and an antibiotic/steroid ointment will be placed in the eye, which will then be patched.

Procedure: Modified technique

Traditional technique for I/A group

ACTIVE COMPARATOR

• In traditional technique group, the cataractous lens will be removed through an anterior continuous curvilinear capsulorhexis (ACCC) that is about 5-6 mm in diameter.

Procedure: Traditional technique

Interventions

Modified technique PROCEDURE

Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule

Modified technique for I/A group

Traditional technique PROCEDURE

Central 5-6 mm curvilinear capsulorhexis of anterior capsule

Traditional technique for I/A group

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1 month and 24 months
• Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
• Informed consent signed by a parent or legal guardian

You may not qualify if:

• Intraocular pressure \>21 mmHg
• Preterm birth (\<28 weeks)
• Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
• History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
• History of ocular trauma
• Microcornea
• Persistent hyperplastic primary vitreous
• Rubella
• Lowe syndrome

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U

Guangzhou, Guangdong, 510060, China

Location

Related Publications (8)

• Wilson ME Jr, Hafez GA, Trivedi RH. Secondary in-the-bag intraocular lens implantation in children who have been aphakic since early infancy. J AAPOS. 2011 Apr;15(2):162-6. doi: 10.1016/j.jaapos.2010.12.008. Epub 2011 Apr 3.

  PMID: 21463960 BACKGROUND

• Grewal DS, Basti S. Modified technique for removal of Soemmerring ring and in-the-bag secondary intraocular lens placement in aphakic eyes. J Cataract Refract Surg. 2012 May;38(5):739-42. doi: 10.1016/j.jcrs.2012.02.023.

  PMID: 22520301 BACKGROUND

• Shrestha UD. Cataract surgery in children: controversies and practices. Nepal J Ophthalmol. 2012 Jan-Jun;4(1):138-49. doi: 10.3126/nepjoph.v4i1.5866.

  PMID: 22344012 BACKGROUND

• Tassignon MJ, Gobin L, Mathysen D, Van Looveren J, De Groot V. Clinical outcomes of cataract surgery after bag-in-the-lens intraocular lens implantation following ISO standard 11979-7:2006. J Cataract Refract Surg. 2011 Dec;37(12):2120-9. doi: 10.1016/j.jcrs.2011.06.025.

  PMID: 22108108 BACKGROUND

• Amon M. Surgical management challenges and clinical results of bimanual micro-incision phacoemulsification cataract surgery in children with congenital cataract. Nepal J Ophthalmol. 2011 Jan-Jun;3(1):3-8. doi: 10.3126/nepjoph.v3i1.4270.

  PMID: 21505539 BACKGROUND

• Nihalani BR, VanderVeen DK. Technological advances in pediatric cataract surgery. Semin Ophthalmol. 2010 Sep-Nov;25(5-6):271-4. doi: 10.3109/08820538.2010.518836.

  PMID: 21091011 BACKGROUND

• Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.

  PMID: 22921386 BACKGROUND

• Luo L, Lin H, Chen W, Wang C, Zhang X, Tang X, Liu J, Congdon N, Chen J, Lin Z, Liu Y. In-the-bag intraocular lens placement via secondary capsulorhexis with radiofrequency diathermy in pediatric aphakic eyes. PLoS One. 2013 Apr 24;8(4):e62381. doi: 10.1371/journal.pone.0062381. Print 2013.

  PMID: 23638058 BACKGROUND

Related Links

• Home page for Zhongshan Ophthalmic Center
• Website for children cataract home

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yizhi Liu, Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: April 28, 2013
• First Posted: May 1, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CN (1)