Clinical trial NCT04436198: Capsular Tension Rings in Intraocular Lens Rotation
Official title: The Investigation of Capsular Tension Rings in Intraocular Lens Rotation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Ophthalmoplegia
Ophthalmologic Complication
Keywords: ophthalmology
capsular tension ring
rotation
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2020-06-17
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
affiliation: United States Air Force
name: Rachel A Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.
citation: Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. doi: 10.1016/s0886-3350(13)80232-5.
citation: Holland E, Lane S, Horn JD, Ernest P, Arleo R, Miller KM. The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. Ophthalmology. 2010 Nov;117(11):2104-11. doi: 10.1016/j.ophtha.2010.07.033. Epub 2010 Sep 16.
citation: Felipe A, Artigas JM, Diez-Ajenjo A, Garcia-Domene C, Alcocer P. Residual astigmatism produced by toric intraocular lens rotation. J Cataract Refract Surg. 2011 Oct;37(10):1895-901. doi: 10.1016/j.jcrs.2011.04.036. Epub 2011 Aug 23.
citation: Rastogi A, Khanam S, Goel Y; Kamlesh; Thacker P, Kumar P. Comparative evaluation of rotational stability and visual outcome of toric intraocular lenses with and without a capsular tension ring. Indian J Ophthalmol. 2018 Mar;66(3):411-415. doi: 10.4103/ijo.IJO_875_17.
citation: Shah GD, Praveen MR, Vasavada AR, Vasavada VA, Rampal G, Shastry LR. Rotational stability of a toric intraocular lens: influence of axial length and alignment in the capsular bag. J Cataract Refract Surg. 2012 Jan;38(1):54-9. doi: 10.1016/j.jcrs.2011.08.028. Epub 2011 Nov 4.
citation: Zhao Y, Li J, Yang K, Li X, Zhu S. Combined Special Capsular Tension Ring and Toric IOL Implantation for Management of Astigmatism and High Axial Myopia with Cataracts. Semin Ophthalmol. 2018;33(3):389-394. doi: 10.1080/08820538.2016.1247181. Epub 2016 Dec 22.
citation: 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.
citation: Sagiv O, Sachs D. Rotation stability of a toric intraocular lens with a second capsular tension ring. J Cataract Refract Surg. 2015 May;41(5):1098-9. doi: 10.1016/j.jcrs.2015.04.004. Epub 2015 Apr 28.
citation: Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.