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no longer feasible
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group: toric IOL plus capsular tension ring | Experimental |
| |
| Control group: toric IOL only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Rachel A Lieberman, MD | United States Air Force | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10724827 | Background | Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007. | |
| 7996408 | 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. |
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We do not plan on sharing data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 12 participants, with one single participant contributing 1 eye to control and 1 eye to treatment. The participant is therefore double counted as they have an eye in control and an eye in treatment. Total has been adjusted to reflect that there were 12 participants total even though 13 were calculated due to the calculator calculating eyes as units, not participants as units.
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Full Range | degree of rotation | 6 months | eyes | eyes |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | Regional Clinical Investigation Program | 7026533583 | amanda.j.crawford.ctr@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2022 | May 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D009886 | Ophthalmoplegia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
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|
| 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). |
|
| 20846724 | 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. |
| 21865007 | 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. |
| 29480253 | 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. |
| 22055077 | 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. |
| 28005433 | 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. |
| 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. |
| 25937341 | 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. |
| 30413154 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| Count of Units |
| eyes |
| eyes |
|
| Sex: Female, Male | As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows. | Count of Units | eyes | eyes |
|
| Race (NIH/OMB) | As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows. | Count of Units | eyes | eyes |
|
| Region of Enrollment | As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows. | Number | eyes | eyes |
|
| OG001 | 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). |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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). | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009422 |
| Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |