Capsular Tension Rings in Intraocular Lens Rotation

Rachel Lieberman

Status: Terminated

Conditions: Ophthalmologic Complication; Cataract; Ophthalmoplegia

Treatments: Device: Toric IOL Only; Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04436198

FWH20200112H

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Treatment group: toric IOL plus capsular tension ring

Experimental group

Treatment:

Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C

Control group: toric IOL only

Active Comparator group

Treatment:

Device: Toric IOL Only