Clinical trial NCT05526781: Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System
Official title: Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Eye Consultants of Atlanta
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-09-02
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be presenting for cataract surgery and who are interested in and appropriate candidates for intraocular lens implantation.

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.

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.

Primary outcomes:
measure: Monocular Uncorrected Distance Visual Acuity (6m)
timeFrame: 3 months postoperative
measure: Binocular Uncorrected Distance Visual Acuity (6m)
timeFrame: 3 months postoperative
measure: Binocular Corrected Distance Visual Acuity (6m)
timeFrame: 3 months postoperative
measure: Monocular Corrected Distance Visual Acuity (6m)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Monocular Uncorrected Intermediate Visual Acuity (66cm)
timeFrame: 3 months postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity (66cm)
timeFrame: 3 months postoperative
measure: Binocular Distance Corrected Intermediate Visual Acuity (66cm)
timeFrame: 3 months postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity (66cm)
timeFrame: 3 months postoperative
measure: Manifest Refraction Spherical Equivalent (MRSE)
timeFrame: 3 months postoperative
measure: Overall Surgeon Satisfaction of Monarch IV Delivery Experience
timeFrame: Operative visit (Day 0)
measure: Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV
timeFrame: Operative visit (Day 0)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Eye Consultants of Atlanta
state: Georgia
Study officials:
affiliation: Eye Consultants of Atlanta
name: Joesph Christenbury, MD
role: PRINCIPAL_INVESTIGATOR
References: