Modified Surgical Techniques for Pediatric Cataract Treatment

Cataract Clinical Trial

Official title:

Modified Surgical Techniques for Pediatric Cataract Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844258
• Other study ID #: CCPMOH2010-China3
• Status: Completed
• Phase: N/A
• First received: April 28, 2013
• Last updated: December 21, 2015
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized, controlled clinical trial with the following objectives:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Modified technique
Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule
• Traditional technique
Central 5-6 mm curvilinear capsulorhexis of anterior capsule

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center,Sun Yat-sen U	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications		6 months	Yes
Primary	Incidence of opacification of the visual axis		six months	No
Secondary	Visual function in eyes treated for cataract		6 months	No

External Links

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