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CataractNCT01844258

Modified Surgical Techniques for Pediatric Cataract Treatment

A study testing Modified technique and Traditional technique in people with Cataract, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 month to 24 months
Conditions the study is for
Cataract
What is being tested?
Modified technique and Traditional technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
Mar 2013to Jan 2014
Phase
Interventional
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 1 month to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Persistent hyperplastic primary vitreous
  • Rubella
  • Lowe syndrome

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center,Sun Yat-sen U

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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.

Read the detailed 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.
Conditions
Cataract
Being tested
Modified technique, Traditional technique
Keywords
pediatric cataract, lens regeneration, endogenous lens epithelial stem cells, visual axis opacification, visual function
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified techniqueProcedure or surgery

    Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule

  • Traditional techniqueProcedure or surgery

    Central 5-6 mm curvilinear capsulorhexis of anterior capsule

Study groups in NCT01844258
Study groupRoleWhat they receive
Modified technique for I/A groupExperimental* 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.
Receives: Procedure: Modified technique
Traditional technique for I/A groupActive 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.
Receives: Procedure: Traditional technique

What is being measured

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

  1. Incidence of opacification of the visual axis

    Measured: six months

Secondary outcomes (1)

  1. Visual function in eyes treated for cataract

    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 posted1 May 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844258
Sponsor's protocol ID
CCPMOH2010-China3
Status last verified
Dec 2015
First submitted
28 Apr 2013
Last updated
22 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21463960

  • 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.

    PubMed 22520301

  • 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.

    PubMed 22344012

  • 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.

    PubMed 22108108

  • 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.

    PubMed 21505539

  • 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.

    PubMed 21091011

  • 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.

    PubMed 22921386

  • 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.

    PubMed 23638058

Questions about this trial

What is this clinical trial studying?

A study testing Modified technique and Traditional technique in people with Cataract, run by Sun Yat-sen University at 1 site in China.

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 3 inclusion and 9 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: finished, as of the sponsor's last update on 22 Dec 2015. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of opacification of the visual axis (time frame: six months). 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 NCT01844258, which also lists 8 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 22 Dec 2015.

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