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Secondary Intraocular Lens Implantation in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03240796
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation.

Condition or disease Intervention/treatment Phase
Congenital Cataract Procedure: minimal invasive surgery and secondary IOL implantation Procedure: traditional cataract surgery and secondary IOL implantation Not Applicable

Detailed Description:
Pediatric patients received minimal invasive surgery and traditional lens removal surgery (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy of primary surgery: Group I: the participants received minimal invasive surgery, while in Group II, the participants received a traditional cataract surgery. Investigators perform a secondary intraocular lens implantation for the patients. Investigators compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups after the first and the second surgery, aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: minimal invasive surgery and secondary IOL implantation Procedure: minimal invasive surgery and secondary IOL implantation
We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.

Active Comparator: traditional cataract surgery and secondary IOL implantation Procedure: traditional cataract surgery and secondary IOL implantation

traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit).

Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.





Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter) ]
    measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.


Secondary Outcome Measures :
  1. Visual axis opacification [ Time Frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter) ]
    Visual axis opacification was recorded by standardized slit lamp retroillumination.

  2. High intraocular pressure [ Time Frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter) ]
    measured with Tono-pen tonometer

  3. Bi-ocular visual function [ Time Frame: The examination is performed when the patient is four years old and older, once a year. ]
    determined with synoptophore



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Ages Eligible for Study:   24 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian

Exclusion Criteria:

  • Intraocular pressure >21 mmHg at enrollment 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240796


Contacts
Contact: Jing Li, M.D +86-20-87330341 Reviewborad_SYsU@163.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center,Sun Yat-sen U Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Haotian Lin, Phd    +86-20-87330475    gddlht@gmail.com   
Principal Investigator: Haotian Lin, PhD         
Principal Investigator: Yizhi Liu, PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Haotian Lin, M.D,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03240796     History of Changes
Other Study ID Numbers: CCPMOH2017-China-4
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haotian Lin, Sun Yat-sen University:
congenital cataract
intra-capsular IOL implantation
ciliary sulcus fixation

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases