Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

NCT ID: NCT05461040

Last Updated: 2022-07-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2021-04-30

Brief Summary

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Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV.

Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective randomized control clinical trial. Methods: Patients were randomly assigned to two groups: optic capture without AV (Group 1) or in-the-bag implantation with AV (Group 2). The following variables were compared: visual acuity, intraocular pressure, refractive errors, IOL tilt and decentration, lenticular astigmatism, anterior-posterior synechia, inflammatory cell deposits on IOL and post-operative complications.

Detailed Description

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Conditions

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Cataract, Juvenile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optic capture of Intraocular lens without anterior vitrectomy (Group 1)

Group Type EXPERIMENTAL

optic capture

Intervention Type PROCEDURE

optic capture of Intraocular lens without anterior vitrectomy

in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2).

Group Type EXPERIMENTAL

In-the-bag implantation of Intraocular lens

Intervention Type PROCEDURE

in-the-bag implantation of Intraocular lens with anterior vitrectomy

Interventions

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optic capture

optic capture of Intraocular lens without anterior vitrectomy

Intervention Type PROCEDURE

In-the-bag implantation of Intraocular lens

in-the-bag implantation of Intraocular lens with anterior vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children with congenital or developmental cataracts who had cataract surgery and primary IOL implantation at a tertiary care referral institute were included.
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ali Devebacak

Principal Investigator, Consultant Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Devebacak, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ege University, Department of Ophthalmology

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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OC3506

Identifier Type: -

Identifier Source: org_study_id

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