Study Summary
This trial will look at whether a capsular tension ring device affects the rotation of a toric intraocular lens after surgery.
Eligible Conditions
- Eye Complications
- Cataract
- Ophthalmoplegia
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 6 months
6 months
degree of toric rotation away from target axis in enrolled eye/s
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Control group: toric IOL only
1 of 2
Treatment group: toric IOL plus capsular tension ring
1 of 2
Active Control
Experimental Treatment
13 Total Participants · 2 Treatment Groups
Primary Treatment: MORCHER® EYEJET® CTR Types 14, 14A, and 14C · No Placebo Group · N/A
Treatment group: toric IOL plus capsular tension ring
Device
Experimental Group · 1 Intervention: MORCHER® EYEJET® CTR Types 14, 14A, and 14C · Intervention Types: DeviceControl group: toric IOL only
Device
ActiveComparator Group · 1 Intervention: Toric IOL Only · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
Rachel LiebermanLead Sponsor
Rachel A Lieberman, MDPrincipal InvestigatorUnited States Air Force
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must have access to medical care at Nellis Air Force Base.
Your eyes do not have any issues with the zonular or capsular prior to or during the insertion of the capsular tension ring.
You are an active military member or a Department of Defense (DoD) beneficiary who is 30 years or older and needs cataract surgery.
You have a condition called corneal astigmatism, and your eye surgery plan involves using a specific type of lens called TECNIS IOL to correct it.
References
- Novis, Clive. 2000. “Astigmatism and Toric Intraocular Lenses”. Current Opinion in Ophthalmology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00055735-200002000-00007.
- Shah, Gauri D., Mamidipudi R. Praveen, Abhay R. Vasavada, Viraj A. Vasavada, Gauri Rampal, and Lajja R. Shastry. 2012. “Rotational Stability of a Toric Intraocular Lens: Influence of Axial Length and Alignment in the Capsular Bag”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2011.08.028.
- Jung, Na Yeon, Dong Hui Lim, Sung Soon Hwang, Joo Hyun, and Tae-Young Chung. 2018. “Comparison of Clinical Outcomes of Toric Intraocular Lens, Precizon Vs Tecnis: A Single Center Randomized Controlled Trial”. BMC Ophthalmology. Springer Science and Business Media LLC. doi:10.1186/s12886-018-0955-3.
- Felipe, Adelina, José M. Artigas, Amparo Díez-Ajenjo, Carmen García-Domene, and Pablo Alcocer. 2011. “Residual Astigmatism Produced by Toric Intraocular Lens Rotation”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2011.04.036.
- Zhao, Yang, Jiaxin Li, Ke Yang, Xiao Li, and Siquan Zhu. 2016. “Combined Special Capsular Tension Ring and Toric IOL Implantation for Management of Astigmatism and High Axial Myopia with Cataracts”. Seminars in Ophthalmology. Informa UK Limited. doi:10.1080/08820538.2016.1247181.
- Shimizu, Kimiya, Akiko Misawa, and Yoko Suzuki. 1994. “Toric Intraocular Lenses: Correcting Astigmatism While Controlling Axis Shift”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0886-3350(13)80232-5.
- Holland, Edward, Stephen Lane, Jeffrey D. Horn, Paul Ernest, Robert Arleo, and Kevin M. Miller. 2010. “The Acrysof Toric Intraocular Lens in Subjects with Cataracts and Corneal Astigmatism”. Ophthalmology. Elsevier BV. doi:10.1016/j.ophtha.2010.07.033.
- Goel, Yashpal, Anju Rastogi, Samreen Khanam, Kamlesh, Prolima Thacker, and Prateek Kumar. 2018. “Comparative Evaluation of Rotational Stability and Visual Outcome of Toric Intraocular Lenses with and Without a Capsular Tension Ring”. Indian Journal of Ophthalmology. Medknow. doi:10.4103/ijo.ijo_875_17.
- Sagiv, Oded, and Dan Sachs. 2015. “Rotation Stability of a Toric Intraocular Lens with a Second Capsular Tension Ring”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2015.04.004.
- Jung, Na Yeon, Dong Hui Lim, Sung Soon Hwang, Joo Hyun, and Tae-Young Chung. 2018. “Comparison of Clinical Outcomes of Toric Intraocular Lens, Precizon Vs Tecnis: A Single Center Randomized Controlled Trial”. BMC Ophthalmology. Springer Science and Business Media LLC. doi:10.1186/s12886-018-0955-3.
- 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.
- 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.
- Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.
- 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.
- 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.
- Rachel Lieberman 2020. "Capsular Tension Rings in Intraocular Lens Rotation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04436198.
Frequently Asked Questions
Are there any opportunities to take part in this research currently?
"Indeed, the clinicaltrials.gov entry signifies that this trial is actively recruiting participants. This medical experiment was initially published on September 1st 2020 and updated most recently in January 13th 2022 with a goal of enrolling 50 patients at one location." - Anonymous Online Contributor
Unverified Answer
What is the magnitude of individuals involved in this trial?
"Affirmative. The details found on clinicaltrials.gov suggest that this healthcare trial is recruiting new subjects. It was initially shared on September 1st 2020, and updated most recently on January 13th 2022; 50 participants are desired from a single medical centre." - Anonymous Online Contributor
Unverified Answer