Secondary Intraocular Lens Implantation in Pediatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Congenital Cataract

Intervention / Treatment
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* Procedure: minimal invasive surgery and secondary IOL implantation
* Procedure: traditional cataract surgery and secondary IOL implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 72 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minimal invasive surgery and secondary IOL implantation<br> | Procedure: minimal invasive surgery and secondary IOL implantation<br>* 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.<br>|
| Active Comparator: traditional cataract surgery and secondary IOL implantation<br> | Procedure: traditional cataract surgery and secondary IOL implantation<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital cataract, intra-capsular IOL implantation, ciliary sulcus fixation