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Completed

NCT Number: NCT05461040

Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

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.

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Key information

Conditions

Cataract, Juvenile Cataract Eye Diseases Lens Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Traumatic or uveitic cataract, corneal opacity, iris coloboma, microphthalmia, microcornea, persistent fetal vascularization, congenital glaucoma, and retinopathy of prematurity were all considered exclusion criteria.

Treatment and study plan

optic capture

Procedure

optic capture of Intraocular lens without anterior vitrectomy

In-the-bag implantation of Intraocular lens

Procedure

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

Primary outcomes

  1. The prevalence of visual axis opacification

    Time frame: through study completion, an average of 2 years

    Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.

  2. The prevalence of inflammatory deposits on Intraocular lens surface

    Time frame: through study completion, an average of 2 years

    Eyes were evaluated presence of inflammatory deposits between the margins of capsulorhexis at the slit lamp examinations.

  3. The prevalence of anterior-posterior synechia

    Time frame: through study completion, an average of 2 years

    Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.

  4. Measurements of Intraocular lens tilt and decentration.

    Time frame: at the postoperative one-year

    Measurement of Intraocular lens (IOL) position at vertical and horizontal meridians at the Scheimpflug images captured with corneal topography. Scheimpflug images were obtained (Pentacam HR, Oculus Optikgerate Gmbh, Wetzlar, Germany) at one postoperative year. The horizontal and vertical meridians' photographs were analyzed.These images were processed in AutoCAD LT 2020 2D CAD software for IOL position assessment.(1) IOL Center: Two arches were drawn that fit perfectly on the anterior and posterior surfaces of the IOL. The points where these two arcs met were marked. Between these intersection points, a line was drawn. The midpoint of this line was accepted as the IOL center. (2) IOL Decentration: It was determined by measuring the distance (mm) from the IOL center point to the pupillary axis. (3) IOL Tilt: Angle (degree) between the IOL axis and the line passing through the iridocorneal angle.

  5. Prediction error

    Time frame: at the post-operative one-month

    Refraction prediction error (PE) was found by subtracting the early post-operative refraction from the pre-operative target refraction.

Secondary outcomes

  1. Intraocular pressure

    Time frame: at the postoperative one year

    Intraocular pressure was measured by Tonopen (Reichart Technologies, Depew, NY), Perkins handheld Mk2 tonometry (Haag-Streit, Koeniz, Switzerland) or Goldmann applanation tonometry (Haag Streit, Koeniz, Switzerland), considering the patient's age and compliance.

  2. Lenticular astigmatism

    Time frame: One-year postoperatively

    Calculated by subtracting corneal astigmatism from manifest astigmatism.

  3. Posterior segment complications

    Time frame: through study completion, an average of 2 years

    In the fundoscopic examination, the patients were evaluated for possible posterior segment complications such as retinal detachment, cystoid macular edema, and intraocular hemorrhage.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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