Capsular Tension Rings in Intraocular Lens Rotation

Not Applicable

Terminated

• Conditions: Cataract; Ophthalmologic Complication; Ophthalmoplegia
• Interventions: Device: Toric IOL Only; Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C

• Registration Number: NCT04436198
• Lead Sponsor: Rachel Lieberman

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.

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 Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Study Start: 2020-09-01
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Results First Submitted: 2024-05-29
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group: toric IOL only	Toric IOL Only	-
Treatment group: toric IOL plus capsular tension ring	MORCHER® EYEJET® CTR Types 14, 14A, and 14C	-

Primary Outcome Measures

Name	Time	Method
Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s	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).

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States