Back to resultsOptic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
Primary Purpose
Cataract, Juvenile
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
optic capture
In-the-bag implantation of Intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract, Juvenile focused on measuring cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
Eligibility Criteria
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.
Sites / Locations
- Ege University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Optic capture of Intraocular lens without anterior vitrectomy (Group 1)
in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2).
Arm Description
Outcomes
Primary Outcome Measures
The prevalence of visual axis opacification
Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.
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.
The prevalence of anterior-posterior synechia
Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.
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.
Prediction error
Refraction prediction error (PE) was found by subtracting the early post-operative refraction from the pre-operative target refraction.
Secondary Outcome Measures
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.
Lenticular astigmatism
Calculated by subtracting corneal astigmatism from manifest astigmatism.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05461040
Brief Title
Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
Official Title
Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Juvenile
Keywords
cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optic capture of Intraocular lens without anterior vitrectomy (Group 1)
Arm Type
Experimental
Arm Title
in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2).
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
optic capture
Intervention Description
optic capture of Intraocular lens without anterior vitrectomy
Intervention Type
Procedure
Intervention Name(s)
In-the-bag implantation of Intraocular lens
Intervention Description
in-the-bag implantation of Intraocular lens with anterior vitrectomy
Primary Outcome Measure Information:
Title
The prevalence of visual axis opacification
Description
Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.
Time Frame
through study completion, an average of 2 years
Title
The prevalence of inflammatory deposits on Intraocular lens surface
Description
Eyes were evaluated presence of inflammatory deposits between the margins of capsulorhexis at the slit lamp examinations.
Time Frame
through study completion, an average of 2 years
Title
The prevalence of anterior-posterior synechia
Description
Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.
Time Frame
through study completion, an average of 2 years
Title
Measurements of Intraocular lens tilt and decentration.
Description
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.
Time Frame
at the postoperative one-year
Title
Prediction error
Description
Refraction prediction error (PE) was found by subtracting the early post-operative refraction from the pre-operative target refraction.
Time Frame
at the post-operative one-month
Secondary Outcome Measure Information:
Title
Intraocular pressure
Description
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.
Time Frame
at the postoperative one year
Title
Lenticular astigmatism
Description
Calculated by subtracting corneal astigmatism from manifest astigmatism.
Time Frame
One-year postoperatively
Title
Posterior segment complications
Description
In the fundoscopic examination, the patients were evaluated for possible posterior segment complications such as retinal detachment, cystoid macular edema, and intraocular hemorrhage.
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Devebacak, M.D.
Organizational Affiliation
Ege University, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University
City
Izmir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
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