Clinical trial NCT06122103: Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
Official title: Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Gainesville Eye Associates
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-11-08
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible participants will be adult normal astigmatic (≥ 0.75D corneal astigmatism) cataract patients presenting for cataract surgery who are considered appropriate candidates for intraocular lens implantation.

Brief 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.


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 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.

Primary outcomes:
measure: Binocular corrected distance visual acuity (CDVA)
timeFrame: 3 months postop
Secondary outcomes:
measure: Binocular uncorrected distance visual acuity (UDVA)
timeFrame: 3 months postop
measure: Binocular distance corrected intermediate visual acuity (DCIVA)
timeFrame: 3 months postop
measure: Binocular uncorrected intermediate visual acuity (UIVA)
timeFrame: 3 months postop
measure: Monocular corrected distance visual acuity (CDVA)
timeFrame: 3 months postop
measure: Monocular uncorrected distance visual acuity (UDVA)
timeFrame: 3 months postop
measure: Monocular distance corrected intermediate visual acuity (DCIVA)
timeFrame: 3 months postop
measure: Monocular uncorrected intermediate visual acuity (UIVA)
timeFrame: 3 months postop
Other outcomes:
measure: Binocular distance-corrected near visual acuity (DCNVA)
timeFrame: 3 months postop
measure: Binocular uncorrected near visual acuity (UNVA)
timeFrame: 3 months postop
measure: Monocular distance corrected defocus curve
timeFrame: 3 months postop
measure: Binocular distance corrected defocus curve
timeFrame: 3 months postop
measure: Manifest refraction
timeFrame: 3 months postop
measure: Patient reported spectacle usage questionnaire (PRSIQ)
timeFrame: 3 months postop
measure: Higher order aberrations
timeFrame: 3 months postop
Locations:
city: Gainesville
country: United States
facility: Gainesville Eye Associates
state: Georgia
Study officials:
affiliation: Gainesville Eye Associates
name: Clayton G Blehm, MD
role: PRINCIPAL_INVESTIGATOR
References: