NCT04436198

Capsular Tension Rings in Intraocular Lens Rotation

The Investigation of Capsular Tension Rings in Intraocular Lens Rotation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rachel Lieberman · Federal
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cataract
• Ophthalmoplegia
• Ophthalmologic Complication

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2020-06-17
• Last updated: 2024-08-19
• Results posted: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study