Cataract
Conditions
Brief summary
To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.
Detailed description
This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.
Interventions
DEVICEClareon monofocal Intraocular lens (toric and non-toric models)
Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Sponsors
Sengi
Eye Consultants of Atlanta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV. * Able to provide written informed consent for participation in the study. * All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV. * Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monocular Corrected Distance Visual Acuity (6m) | 3 months postoperative |
| Binocular Uncorrected Distance Visual Acuity (6m) | 3 months postoperative |
| Binocular Corrected Distance Visual Acuity (6m) | 3 months postoperative |
| Monocular Uncorrected Distance Visual Acuity (6m) | 3 months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Uncorrected Intermediate Visual Acuity (66cm) | 3 months postoperative | — |
| Binocular Uncorrected Intermediate Visual Acuity (66cm) | 3 months postoperative | — |
| Binocular Distance Corrected Intermediate Visual Acuity (66cm) | 3 months postoperative | — |
| Monocular Distance Corrected Intermediate Visual Acuity (66cm) | 3 months postoperative | — |
| Manifest Refraction Spherical Equivalent (MRSE) | 3 months postoperative | The percentage of eyes with MRSE within ± 0.5 D. |
| Overall Surgeon Satisfaction of Monarch IV Delivery Experience | Operative visit (Day 0) | Score from 1-5. Higher scores indicate high surgeon satisfaction. Satisfaction was determined as the percentages of eyes where the surgeon was Satisfied or Very Satisfied. |
| Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV | Operative visit (Day 0) | Score from 1-4. Higher scores indicate higher consistency. Outcome measure is the percentage of eyes where the IOL from cartridge coming out as planar, able to deliver IOL easily and smoothly into capsular bag. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | — |
|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 6.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Sex Female | 13 Participants | — |
| Sex/Gender, Customized Sex Male | 13 Participants | — |
| Sex/Gender, Customized Sex Not Disclosed | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Binocular Corrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Binocular Corrected Distance Visual Acuity (6m) | 0.00 logMAR | Standard Deviation 0.02 |
Primary
Binocular Uncorrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Binocular Uncorrected Distance Visual Acuity (6m) | 0.03 logMAR | Standard Deviation 0.04 |
Primary
Monocular Corrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Monocular Corrected Distance Visual Acuity (6m) | 0.00 logMAR | Standard Deviation 0.02 |
Primary
Monocular Uncorrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Monocular Uncorrected Distance Visual Acuity (6m) | 0.06 logMAR | Standard Deviation 0.07 |
Secondary
Binocular Distance Corrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Binocular Distance Corrected Intermediate Visual Acuity (66cm) | 0.0 logMAR | Standard Deviation 0.05 |
Secondary
Binocular Uncorrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Binocular Uncorrected Intermediate Visual Acuity (66cm) | 0.09 logMAR | Standard Deviation 0.05 |
Secondary
Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV
Score from 1-4. Higher scores indicate higher consistency. Outcome measure is the percentage of eyes where the IOL from cartridge coming out as planar, able to deliver IOL easily and smoothly into capsular bag.
Time frame: Operative visit (Day 0)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV | 50 eyes |
Secondary
Manifest Refraction Spherical Equivalent (MRSE)
The percentage of eyes with MRSE within ± 0.5 D.
Time frame: 3 months postoperative
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Manifest Refraction Spherical Equivalent (MRSE) | 51 eyes |
Secondary
Monocular Distance Corrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Monocular Distance Corrected Intermediate Visual Acuity (66cm) | 0.05 logMAR | Standard Deviation 0.05 |
Secondary
Monocular Uncorrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Monocular Uncorrected Intermediate Visual Acuity (66cm) | 0.12 logMAR | Standard Deviation 0.05 |
Secondary
Overall Surgeon Satisfaction of Monarch IV Delivery Experience
Score from 1-5. Higher scores indicate high surgeon satisfaction. Satisfaction was determined as the percentages of eyes where the surgeon was Satisfied or Very Satisfied.
Time frame: Operative visit (Day 0)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) | Overall Surgeon Satisfaction of Monarch IV Delivery Experience | 56 eyes |