Capsular Tension Rings in Intraocular Lens Rotation

Study Overview
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Brief Summary
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To investigate whether implantation of a capsular tension ring device will affect the degree of rotation of an implanted toric intraocular lens following cataract surgery.

Detailed Description
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The study is a prospective, subject-blinded investigation of whether implanting capsular tension rings with intraocular lenses affects rotational stability of the lens. Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care). Randomization: Each eye undergoing cataract surgery will be randomized into a control or treatment group. If both eyes meet enrollment criteria, then each eye will be randomized independently. Control group: toric IOL only Treatment group: toric IOL plus capsular tension ring

Official Title
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The Investigation of Capsular Tension Rings in Intraocular Lens Rotation

Conditions
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Cataract, Ophthalmoplegia, Ophthalmologic Complication

Intervention / Treatment
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* Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C
* Device: Toric IOL Only


Participation Criteria
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Eligibility Criteria
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Active duty and DoD beneficiaries aged 30 years or older undergoing cataract surgery Corneal astigmatism ≥ 1.0 D and a surgical plan that includes a toric intraocular lens for astigmatism correction. (The lens used will be the TECNIS IOL. It will be used on label) No observed zonular or capsular problems prior to, or at the time of, capsular tension ring insertion Exclusion Criteria: Patients undergoing cataract surgery who do not have corneal astigmatism ≥1.0 D. Any observed zonular or capsular problems prior to, or at the time of, capsular tension ring insertion. Pre-existing ocular conditions, including:Pre-existing ocular conditions, including: Pseudoexfoliation syndrome in one or both eyes Prior incisional ocular surgery Lens subluxation Poor dilation or inability to position at the slit lamp (making postoperative outcome measurements difficult or impossible) Plans for extensive travel or to move away during the postoperative evaluation period Other conditions that would influence the capsule or lens positioning Surgical plan to include other procedures at the time of initial cataract surgery, such as Limbal Relaxing Incisions (LRIs), Micro-Incisional Glaucoma Surgery (MIGS), etc.

Ages Eligible for Study
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Minimum Age: 30 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: Treatment group: toric IOL plus capsular tension ring<br> | Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C<br>* Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention: Axial length > 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length < 24.0 mm: CTR model 14 Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).<br>|
| Active Comparator: Control group: toric IOL only<br> | Device: Toric IOL Only<br>* Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring. Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of toric rotation away from target axis in enrolled eye/s | The eye(s) enrolled in the study will be dilated and slit lamp photography taken using retroillumination. The capsular tension ring will not be visible in the slit lamp photos or during the eye exams. The patient will be blinded as to which eye is in the treatment or control group. The slit lamp photos will be de-identified and used to determine the axis of the toric IOL by evaluators blinded to the patient identity and control/treatment group. The toric axis will be identified using either ImageJ (NIH) or Adobe Illustrator by measuring the angle between a straight line drawn across the toric axis markers and a straight line at the horizontal axis (0 degrees). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ophthalmology, capsular tension ring, rotation