Secondary Intraocular Lens Implantation in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Congenital Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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minimal invasive surgery and secondary IOL implantation

Group Type EXPERIMENTAL

minimal invasive surgery and secondary IOL implantation

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

traditional cataract surgery and secondary IOL implantation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

24 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No