Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clareon Monofocal
|
Device: Clareon Monofocal
Clareon Monofocal Intraocular Lens (toric and non-toric)
|
| Light-Adjustable Lens
|
Device: Light-Adjustable Lens
Light-Adjustable Lens (Intraocular Lens)
|
Outcome Measures
Primary Outcome Measures
- Binocular corrected distance visual acuity (CDVA) [3 months postop]
Secondary Outcome Measures
- Binocular uncorrected distance visual acuity (UDVA) [3 months postop]
- Binocular distance corrected intermediate visual acuity (DCIVA) [3 months postop]
- Binocular uncorrected intermediate visual acuity (UIVA) [3 months postop]
- Monocular corrected distance visual acuity (CDVA) [3 months postop]
- Monocular uncorrected distance visual acuity (UDVA) [3 months postop]
- Monocular distance corrected intermediate visual acuity (DCIVA) [3 months postop]
- Monocular uncorrected intermediate visual acuity (UIVA) [3 months postop]
Other Outcome Measures
- Binocular distance-corrected near visual acuity (DCNVA) [3 months postop]
- Binocular uncorrected near visual acuity (UNVA) [3 months postop]
- Monocular distance corrected defocus curve [3 months postop]
- Binocular distance corrected defocus curve [3 months postop]
- Manifest refraction [3 months postop]
MRSE, residual sphere, and residual astigmatism
- Patient reported spectacle usage questionnaire (PRSIQ) [3 months postop]
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.
- Higher order aberrations [3 months postop]
Eligibility Criteria
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.
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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.
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History of corneal refractive and intraocular surgery.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gainesville Eye Associates | Gainesville | Georgia | United States | 30501 |
Sponsors and Collaborators
- Gainesville Eye Associates
- Sengi
Investigators
- Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CB-23-02