Secondary Intraocular Lens Implantation in Pediatric Patients

Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Cataract
• Intervention / Treatment: Procedure: minimal invasive surgery and secondary IOL implantation; Procedure: traditional cataract surgery and secondary IOL implantation

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
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center,Sun Yat-sen U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual axis opacification	Visual axis opacification was recorded by standardized slit lamp retroillumination.	recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
High intraocular pressure	measured with Tono-pen tonometer	recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)
Bi-ocular visual function	determined with synoptophore	The examination is performed when the patient is four years old and older, once a year.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Haotian Lin, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: congenital cataract; intra-capsular IOL implantation; ciliary sulcus fixation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2017-China-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No