Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System
Source: ClinicalTrials.gov NCT05526781 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Uncorrected Distance Visual Acuity (6m) |
0.06 | — |
| PRIMARY Binocular Uncorrected Distance Visual Acuity (6m) |
0.03 | — |
| PRIMARY Binocular Corrected Distance Visual Acuity (6m) |
0.00 | — |
| PRIMARY Monocular Corrected Distance Visual Acuity (6m) |
0.00 | — |
| SECONDARY Monocular Uncorrected Intermediate Visual Acuity (66cm) |
0.12 | — |
| SECONDARY Binocular Uncorrected Intermediate Visual Acuity (66cm) |
0.09 | — |
| SECONDARY Binocular Distance Corrected Intermediate Visual Acuity (66cm) |
0.0 | — |
| SECONDARY Monocular Distance Corrected Intermediate Visual Acuity (66cm) |
0.05 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) |
51 | — |
| SECONDARY Overall Surgeon Satisfaction of Monarch IV Delivery Experience |
56 | — |
| SECONDARY Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV |
50 | — |
Eligibility Criteria
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 exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye.
- History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis.
- History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery.
- History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's Johnson Syndrome.
- History of glaucoma.
The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Data sourced from ClinicalTrials.gov (NCT05526781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.