Capsular Tension Rings in Intraocular Lens Rotation

NCT04436198 | Terminated Results DMC FDA Device

• 1 other identifier: FWH20200112H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Ophthalmoplegia; Ophthalmologic Complication

Keywords

ophthalmology; capsular tension ring; rotation

Outcome Measures

Primary Outcomes (1)

• Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s

  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).

  6 months

Study Arms (2)

Treatment group: toric IOL plus capsular tension ring

EXPERIMENTAL

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

Control group: toric IOL only

ACTIVE COMPARATOR

Device: Toric IOL Only

Interventions

MORCHER® EYEJET® CTR Types 14, 14A, and 14C DEVICE

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).

Treatment group: toric IOL plus capsular tension ring

Toric IOL Only DEVICE

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).

Control group: toric IOL only

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rachel Lieberman: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (10)

• Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.

  PMID: 10724827 BACKGROUND

• 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.

  PMID: 7996408 BACKGROUND

• 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.

  PMID: 20846724 BACKGROUND

• 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.

  PMID: 21865007 BACKGROUND

• 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.

  PMID: 29480253 BACKGROUND

• 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.

  PMID: 22055077 BACKGROUND

• 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.

  PMID: 28005433 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25937341 BACKGROUND

• 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.

  PMID: 30413154 BACKGROUND

MeSH Terms

Conditions

Cataract; Ophthalmoplegia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amanda Crawford
• Organization: Regional Clinical Investigation Program

amanda.j.crawford.ctr@health.mil

7026533583

Study Officials

• Rachel A Lieberman, MD

  United States Air Force

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 17, 2020
• Study Start: September 1, 2020
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)