An interventional study of MORCHER® EYEJET® CTR Types 14, 14A, and 14C and Toric IOL Only in Cataract, Ophthalmoplegia and Ophthalmologic Complication, sponsored by Rachel Lieberman. Terminated at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Rachel Lieberman · Not applicable, Interventional, and Treatment
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.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 1,171 interventional studies indexed under Cataract.
Browse Cataract studies →This is the only study on the registry with Rachel Lieberman as lead sponsor.
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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:
Pre-existing ocular conditions, including:Pre-existing ocular conditions, including:
Device: MORCHER® EYEJET® CTR Types 14, 14A, and 14C
Device: Toric IOL Only
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. 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).
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).
Time frame: 6 months
| Milestone | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only |
|---|---|---|
| Started | 7 | 6 |
| Completed | 5 | 3 |
| Not completed | 2 | 3 |
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).
| degree of rotation | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only |
|---|---|---|
| average difference between intended toric axis (degrees) | 5.739 (.506 to 11.383) | 3 (2.82 to 15.5173) |
| average difference between intended axis (degrees) | 5 (1 to 13) | 10 (7 to 13) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group: Toric IOL Plus Capsular Tension Ring | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Control Group: Toric IOL Only | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
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.
| Age, Categorical(eyes) | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 1 | 1 |
| >=65 years | 7 | 5 | 12 |
| Sex: Female, Male(eyes) | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 2 | 3 | 5 |
| Race (NIH/OMB)(eyes) | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 4 | 3 | 7 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(eyes) | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only | Total |
|---|---|---|---|
| United States | 2 | 4 | 6 |
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Plan to share: No — We do not plan on sharing data.
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