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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intraocular Lens Rotation, Capsular Tension Ring

Intervention / Treatment
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* Device: Implantation of an intraocular lens


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 95 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axis 0<br>IOL Implantation at the 0 +/- 10 degrees axis | Device: Implantation of an intraocular lens<br>* Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.<br>|
| Experimental: Axis 45<br>IOL Implantation at the 45 +/- 10 degrees axis | Device: Implantation of an intraocular lens<br>* Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.<br>|
| Experimental: Axis 90<br>IOL Implantation at the 90 +/- 10 degrees axis | Device: Implantation of an intraocular lens<br>* Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.<br>|
| Experimental: Axis 135<br>IOL Implantation at the 135 +/- 10 degrees axis | Device: Implantation of an intraocular lens<br>* Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of axial intraocular lens position | 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°) | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decentration | Decentration of the intraocular lens will be measured with the Casia 2 OCT. Decentration will be described as Decentration in millimeter | 7 months | 
| Tilt | 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 | 7 months | 
| Anterior chamber depth | 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 | 7 months | 
| Best corrected visual acuity (BCVA) | 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) | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens rotation, capsular tension ring, postoperative tilt & decentration