Cataract, Ophthalmologic Complication, Ophthalmoplegia
Conditions
Keywords
ophthalmology, capsular tension ring, rotation
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
Interventions
DEVICEMORCHER® 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).
DEVICEToric 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).
Sponsors
Rachel Lieberman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s | 6 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 7 |
| 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). | 7 |
| 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). | 6 |
| 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). | 6 |
| Total | 26 |
Baseline characteristics
| Characteristic | Treatment Group: Toric IOL Plus Capsular Tension Ring | Control Group: Toric IOL Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 eyes | 0 eyes | 0 eyes |
| Age, Categorical >=65 years | 7 eyes | 5 eyes | 12 eyes |
| Age, Categorical Between 18 and 65 years | 0 eyes | 1 eyes | 1 eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) Asian | 1 eyes | 1 eyes | 2 eyes |
| Race (NIH/OMB) Black or African American | 1 eyes | 0 eyes | 1 eyes |
| Race (NIH/OMB) More than one race | 1 eyes | 1 eyes | 2 eyes |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 eyes | 1 eyes | 1 eyes |
| Race (NIH/OMB) Unknown or Not Reported | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) White | 4 eyes | 3 eyes | 7 eyes |
| Region of Enrollment United States | 2 eyes | 4 eyes | 6 eyes |
| Sex: Female, Male Female | 5 eyes | 3 eyes | 8 eyes |
| Sex: Female, Male Male | 2 eyes | 3 eyes | 5 eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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).
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment Group: Toric IOL Plus Capsular Tension Ring | Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s | average difference between intended toric axis (degrees) | 5.739 degree of rotation |
| Treatment Group: Toric IOL Plus Capsular Tension Ring | Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s | average difference between intended axis (degrees) | 5 degree of rotation |
| Control Group: Toric IOL Only | Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s | average difference between intended toric axis (degrees) | 3 degree of rotation |
| Control Group: Toric IOL Only | Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s | average difference between intended axis (degrees) | 10 degree of rotation |