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.

Study Overview

• Status: Completed
• Conditions: Cataract, Juvenile
• Intervention / Treatment: Procedure: optic capture; Procedure: In-the-bag implantation of Intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Optic capture of Intraocular lens without anterior vitrectomy (Group 1)	Procedure: optic capture; optic capture of Intraocular lens without anterior vitrectomy
EXPERIMENTAL: in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2).	Procedure: In-the-bag implantation of Intraocular lens; in-the-bag implantation of Intraocular lens with anterior vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of visual axis opacification	Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.	through study completion, an average of 2 years
The prevalence of inflammatory deposits on Intraocular lens surface	Eyes were evaluated presence of inflammatory deposits between the margins of capsulorhexis at the slit lamp examinations.	through study completion, an average of 2 years
The prevalence of anterior-posterior synechia	Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.	through study completion, an average of 2 years
Measurements of Intraocular lens tilt and decentration.	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.	at the postoperative one-year
Prediction error	Refraction prediction error (PE) was found by subtracting the early post-operative refraction from the pre-operative target refraction.	at the post-operative one-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	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.	at the postoperative one year
Lenticular astigmatism	Calculated by subtracting corneal astigmatism from manifest astigmatism.	One-year postoperatively
Posterior segment complications	In the fundoscopic examination, the patients were evaluated for possible posterior segment complications such as retinal detachment, cystoid macular edema, and intraocular hemorrhage.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Ali Devebacak, M.D., Ege University, Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2018
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (ACTUAL): July 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: OC3506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No