Modified Surgical Techniques for Pediatric Cataract Treatment
NCT ID: NCT01844258
Last Updated: 2015-12-22
Study Results
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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COMPLETED
NA
37 participants
INTERVENTIONAL
2013-03-31
2014-01-31
Brief Summary
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Detailed Description
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* To determine whether infants with congenital cataract have improved visual outcomes following cataract extraction surgery using (1) the traditional capsulorhexis method or (2) our new minimally invasive method.
* To determine the occurrence of postoperative complications among infants with congenital cataract following cataract extraction surgery using (1) the traditional capsulorhexis method or (2) our new minimally invasive method.
The study is conducted for the following reasons:
* Transplantation of pluripotent stem cells represents an appealing therapeutic strategy in regenerative medicine, but its clinical applications have been hindered in part by concerns about tumorigenicity and immune rejection. The use of endogenous stem cells provides a possible solution to this problem.
* Lens regeneration has been reported in lower vertebrate animals. Furthermore, residual endogenous lens epithelial stem cells (LESCs) after lens removal in rabbits have been shown to proliferate and generate lens fibers.
* Cataract, or opacification of the lens, is a major cause of blindness worldwide. Surgery for congenital cataract carries a significant risk of complications and often requires additional surgical procedures to maintain the transparency of the visual axis.
* Implantation of intraocular lenses (IOLs) following cataract extraction is becoming increasingly common in the pediatric population. However, their use is controversial in children younger than two years old (especially not recommended in children younger than 6 months old due to the high incidences of IOL-related complications), as the refractive power of the eye continues to develop. In addition, IOLs have many limitations, including dislocation, less than ideal biocompatibility, inadequate accommodative properties, and suboptimal visual outcomes.
* The trial will demonstrate whether a modified cataract surgical technique can regenerate the lens from endogenous stem cells. It will also compare the incidence of complications and characterize visual outcomes in pediatric patients treated with the modified surgical technique versus the traditional surgical technique.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified technique for I/A group
* 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.
Modified technique
Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule
Traditional technique for I/A group
• 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.
Traditional technique
Central 5-6 mm curvilinear capsulorhexis of anterior capsule
Interventions
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Modified technique
Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule
Traditional technique
Central 5-6 mm curvilinear capsulorhexis of anterior capsule
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Month
24 Months
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Haotian Lin
Ophthalmologist
Principal Investigators
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Yizhi Liu, Ph.D.
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center,Sun Yat-sen U
Guangzhou, Guangdong, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Home page for Zhongshan Ophthalmic Center
Other Identifiers
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CCPMOH2010-China3
Identifier Type: -
Identifier Source: org_study_id