Study Results
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View full resultsBasic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2020-09-01
2023-04-21
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment group: toric IOL plus capsular tension ring
MORCHER® EYEJET® CTR Types 14, 14A, and 14C
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).
Control group: toric IOL only
Toric IOL Only
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).
Interventions
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MORCHER® EYEJET® CTR Types 14, 14A, and 14C
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).
Toric IOL Only
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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Rachel Lieberman
FED
Responsible Party
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Rachel Lieberman
Principal Investigator
Principal Investigators
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Rachel A Lieberman, MD
Role: PRINCIPAL_INVESTIGATOR
United States Air Force
Locations
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Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Countries
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References
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Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FWH20200112H
Identifier Type: -
Identifier Source: org_study_id
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