Secondary Intraocular Lens Implantation in Pediatric Patients

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240796
• Other study ID #: CCPMOH2017-China-4
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: Jing Li, M.D
• Phone: +86-20-87330341
• Email: Reviewborad_SYsU[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 72 Months

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

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.
• 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Bi-ocular visual function	determined with synoptophore	The examination is performed when the patient is four years old and older, once a year.