Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

Study Overview
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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.

Official Title
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Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery

Conditions
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Cataract, Juvenile

Intervention / Treatment
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* Procedure: optic capture
* Procedure: In-the-bag implantation of Intraocular lens


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optic capture of Intraocular lens without anterior vitrectomy (Group 1)<br> | Procedure: optic capture<br>* optic capture of Intraocular lens without anterior vitrectomy<br>|
| Experimental: in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2).<br> | Procedure: In-the-bag implantation of Intraocular lens<br>* in-the-bag implantation of Intraocular lens with anterior vitrectomy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy