Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

Cataract Clinical Trial

Official title:

Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122103
• Other study ID #: CB-23-02
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: November 2023
• Source: Gainesville Eye Associates
• Contact: MaryAnn Thomas
• Phone: 770-532-4444
• Email: mthomas[@]gainesvilleeye.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 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 patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better

• Regular corneal astigmatism of 0.75D-2.50D

• Dilated pupil diameter of 7mm or greater

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.

• Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.

• History of corneal refractive and intraocular surgery.

• Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.

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
Clareon Monofocal Intraocular Lens (toric and non-toric)
• Light-Adjustable Lens
Light-Adjustable Lens (Intraocular Lens)

Locations

Country	Name	City	State
United States	Gainesville Eye Associates	Gainesville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Gainesville Eye Associates	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Binocular distance-corrected near visual acuity (DCNVA)		3 months postop
Other	Binocular uncorrected near visual acuity (UNVA)		3 months postop
Other	Monocular distance corrected defocus curve		3 months postop
Other	Binocular distance corrected defocus curve		3 months postop
Other	Manifest refraction	MRSE, residual sphere, and residual astigmatism	3 months postop
Other	Patient reported spectacle usage questionnaire (PRSIQ)	Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision.	3 months postop
Other	Higher order aberrations		3 months postop
Primary	Binocular corrected distance visual acuity (CDVA)		3 months postop
Secondary	Binocular uncorrected distance visual acuity (UDVA)		3 months postop
Secondary	Binocular distance corrected intermediate visual acuity (DCIVA)		3 months postop
Secondary	Binocular uncorrected intermediate visual acuity (UIVA)		3 months postop
Secondary	Monocular corrected distance visual acuity (CDVA)		3 months postop
Secondary	Monocular uncorrected distance visual acuity (UDVA)		3 months postop
Secondary	Monocular distance corrected intermediate visual acuity (DCIVA)		3 months postop
Secondary	Monocular uncorrected intermediate visual acuity (UIVA)		3 months postop