Clinical trial NCT03856944: Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Official title: Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Astigmatism
intraocular lens
multifocal
Lead sponsor: Gainesville Eye Associates
Sponsor class: OTHER
Collaborators: name: SiV Consulting
First posted: 2019-02-27
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective, single center, open clinical trial to collect normative performance data.
Primary purpose: TREATMENT

Brief summary: The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.

Detailed description: The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.

Eligibility criteria: Inclusion Criteria:

* Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in the eligible eye.

* Bilateral visually-significant cataracts
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
* Regular corneal astigmatism of 1.00D to 2.50D in both eyes
* Potential postoperative acuity of 20/25 or better

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.

  * Irregular astigmatism (e.g. keratoconus)
  * Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.)
  * Monocular status (e.g. amblyopia)
  * Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty)
  * Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  * Moderate-to-advanced glaucoma
  * Strabismus
  * Use of arcuate incisions for astigmatism management at the time of surgery
  * Diabetic retinopathy
  * Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.)
  * History of retinal detachment
  * Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
  * Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

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: Residual Refractive Cylinder
timeFrame: 3 months
Secondary outcomes:
measure: Monocular Uncorrected Near Visual Acuity
timeFrame: 3 months
measure: Monocular Uncorrected Distance Visual Acuity
timeFrame: 3 months
measure: Monocular Uncorrected Intermediate Visual Acuity
timeFrame: 3 months
measure: Monocular Best Corrected Distance Visual Acuity
timeFrame: 3 months
measure: Monocular Best Distance-corrected Intermediate Visual Acuity
timeFrame: 3 months
measure: Monocular Best Distance-corrected Near Visual Acuity
timeFrame: 3 months
measure: Binocular Uncorrected Near Visual Acuity
timeFrame: 3 months
measure: Binocular Uncorrected Distance Visual Acuity
timeFrame: 3 months
measure: Binocular Uncorrected Intermediate Visual Acuity
timeFrame: 3 months
measure: Binocular Best-corrected Distance Visual Acuity
timeFrame: 3 months
measure: Binocular Best Distance-corrected Intermediate Visual Acuity
timeFrame: 3 months
measure: Binocular Best Distance-corrected Near Visual Acuity
timeFrame: 3 months
measure: IOL Orientation
timeFrame: 3 months
measure: Binocular Best Distance-corrected Defocus Curve
timeFrame: 3 months
measure: Binocular Uncorrected Defocus Curve.
timeFrame: 3 months
measure: Subjective Visual Quality
timeFrame: 3 months
Other outcomes:
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: