Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study

Not Applicable

• Conditions: Intraocular Lens Rotation; Capsular Tension Ring
• Interventions: Device: Implantation of an intraocular lens

• Registration Number: NCT04226196
• Lead Sponsor: Medical University of Vienna

Brief Summary

The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-01-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
• Need for spherical IOL correction between +0.00 and +32.00 D
• Pupil dilation of ≥ 7.0 mm
• Age 45 to 95

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Exclusion Criteria

• Corneal abnormality (Corneal scaring)
• Preceding ocular surgery or trauma
• Uncontrolled glaucoma
• Proliferative diabetic retinopathy
• Iris neovascularization
• History of uveitis/iritis
• Microphthalmus
• Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
• Pregnancy
• Lactation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axis 45	Implantation of an intraocular lens	IOL Implantation at the 45 +/- 10 degrees axis
Axis 135	Implantation of an intraocular lens	IOL Implantation at the 135 +/- 10 degrees axis
Axis 0	Implantation of an intraocular lens	IOL Implantation at the 0 +/- 10 degrees axis
Axis 90	Implantation of an intraocular lens	IOL Implantation at the 90 +/- 10 degrees axis

Primary Outcome Measures

Name	Time	Method
Change of axial intraocular lens position	7 months	Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)

Secondary Outcome Measures

Name	Time	Method
Anterior chamber depth	7 months	The anterior chamber depth (Axial position of the IOL) of the intraocular lens will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in millimeter
Best corrected visual acuity (BCVA)	7 months	BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)
Tilt	7 months	Tilt of the intraocular lens will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
Decentration	7 months	Decentration of the intraocular lens will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in millimeter"

Trial Locations

Locations (1)

Medical University of Vienna Allgemeines Krankenhaus; 🇦🇹 Vienna, Austria