Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract, Juvenile
• Interventions: Procedure: optic capture; Procedure: In-the-bag implantation of Intraocular lens

• Registration Number: NCT05461040
• Lead Sponsor: Ege University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-04-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-13
• Last Update Submitted: 2022-07-13
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optic capture of Intraocular lens without anterior vitrectomy (Group 1)	optic capture	-
in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2).	In-the-bag implantation of Intraocular lens	-

Primary Outcome Measures

Name	Time	Method
The prevalence of inflammatory deposits on Intraocular lens surface	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.
Measurements of Intraocular lens tilt and decentration.	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.
The prevalence of visual axis opacification	through study completion, an average of 2 years	Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.
The prevalence of anterior-posterior synechia	through study completion, an average of 2 years	Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.
Prediction error	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 Outcome Measures

Name	Time	Method
Intraocular pressure	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.
Lenticular astigmatism	One-year postoperatively	Calculated by subtracting corneal astigmatism from manifest astigmatism.
Posterior segment complications	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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey