Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System

Cataract Clinical Trial

Official title:

Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05526781
• Other study ID #: JC-22-001
• Status: Completed
• Start date: September 21, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: April 2024
• Source: Eye Consultants of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Eye Consultants of Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Eye Consultants of Atlanta	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular uncorrected distance visual acuity (6m)		3 months postoperative
Primary	Binocular uncorrected distance visual acuity (6m)		3 months postoperative
Primary	Binocular corrected distance visual acuity (6m)		3 months postoperative
Primary	Monocular corrected distance visual acuity (6m)		3 months postoperative
Secondary	Monocular uncorrected intermediate visual acuity (66cm)		3 months postoperative
Secondary	Binocular uncorrected intermediate visual acuity (66cm)		3 months postoperative
Secondary	Binocular distance corrected intermediate visual acuity (66cm)		3 months postoperative
Secondary	Monocular distance corrected intermediate visual acuity (66cm)		3 months postoperative
Secondary	Manifest refraction	Residual spherical equivalent refraction, residual sphere, and residual astigmatism	3 months postoperative
Secondary	Overall surgeon satisfaction of Monarch IV delivery experience	Score from 1-5. Higher scores indicate high surgeon satisfaction.	Operative visit (Day 0)
Secondary	Consistency of in-the-bag delivery of IOL during implantation with Monarch IV	Score from 1-4. Higher scores indicate higher consistency.	Operative visit (Day 0)