Status:
TERMINATED
Capsular Tension Rings in Intraocular Lens Rotation
Lead Sponsor:
Rachel Lieberman
Conditions:
Cataract
Ophthalmoplegia
Eligibility:
All Genders
30+ years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- \*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04436198
Start Date
September 1 2020
End Date
April 21 2023
Last Update
August 19 2024
Active Locations (1)
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1
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States, 89191