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Capsular Tension Rings in Intraocular Lens Rotation

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ClinicalTrials.gov Identifier: NCT04436198
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Rachel Lieberman, Mike O'Callaghan Military Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Ophthalmoplegia Ophthalmologic Complication Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C Device: Toric IOL Only Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Investigation of Capsular Tension Rings in Intraocular Lens Rotation
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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).





Primary Outcome Measures :
  1. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

**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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436198


Contacts
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Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil

Locations
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United States, Nevada
Mike O'Callaghan Military Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Amanda J Crawford, MSHS    702-653-3298    amanda.j.crawford.ctr@mail.mil   
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Sponsors and Collaborators
Rachel Lieberman
Investigators
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Principal Investigator: Rachel A Lieberman, MD United States Air Force
Publications:
Safran SG. Use of Capsular Tension Ring to Prevent Early Post-operative Rotation of a Toric Intraocular Lens in High Axial Myopia. JCRS Online Case reports. 2015.

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Responsible Party: Rachel Lieberman, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT04436198    
Other Study ID Numbers: FWH20200112H
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rachel Lieberman, Mike O'Callaghan Military Hospital:
ophthalmology
capsular tension ring
rotation
Additional relevant MeSH terms:
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Ophthalmoplegia
Cataract
Lens Diseases
Eye Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations