Capsular Tension Rings in Intraocular Lens Rotation

April 21, 2023 updated by: Rachel Lieberman

The Investigation of Capsular Tension Rings in Intraocular Lens Rotation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

**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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group: toric IOL plus capsular tension ring
Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C

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).
Active Comparator: Control group: toric IOL only
Device: Toric IOL Only

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of toric rotation away from target axis in enrolled eye/s
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rachel Lieberman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20200112H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan on sharing data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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