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Capsular Tension Rings in Intraocular Lens Rotation

Primary Purpose

Cataract, Ophthalmoplegia, Ophthalmologic Complication

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Toric IOL Only

About this trial

This is an interventional treatment trial for Cataract focused on measuring ophthalmology, capsular tension ring, rotation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

**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.

Sites / Locations

Mike O'Callaghan Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group: toric IOL plus capsular tension ring

Control group: toric IOL only

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT04436198

First Posted

May 19, 2020

Last Updated

April 21, 2023

Sponsor

Rachel Lieberman

1. Study Identification

Unique Protocol Identification Number

NCT04436198

Brief Title

Capsular Tension Rings in Intraocular Lens Rotation

Official Title

The Investigation of Capsular Tension Rings in Intraocular Lens Rotation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

no longer feasible

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

April 21, 2023 (Actual)

Study Completion Date

April 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rachel Lieberman

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Ophthalmoplegia, Ophthalmologic Complication

Keywords

ophthalmology, capsular tension ring, rotation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group: toric IOL plus capsular tension ring

Arm Type

Experimental

Arm Title

Control group: toric IOL only

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Toric IOL Only

Intervention Description

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).

Primary Outcome Measure Information:

Title

degree of toric rotation away from target axis in enrolled eye/s

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel A Lieberman, MD

Organizational Affiliation

United States Air Force

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mike O'Callaghan Military Medical Center

City

Nellis Air Force Base

State/Province

Nevada

ZIP/Postal Code

89191

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan on sharing data.

Citations:

PubMed Identifier

10724827

Citation

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

Results Reference

background

PubMed Identifier

7996408

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.

Results Reference

background

PubMed Identifier

20846724

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.

Results Reference

background

PubMed Identifier

21865007

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.

Results Reference

background

PubMed Identifier

29480253

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.

Results Reference

background

PubMed Identifier

22055077

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.

Results Reference

background

PubMed Identifier

28005433

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

25937341

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.

Results Reference

background

PubMed Identifier

30413154

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.

Results Reference

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Capsular Tension Rings in Intraocular Lens Rotation

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