Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models

• Sponsor: Gainesville Eye Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT03856944
• Collaborator: SiV Consulting (Other)
• Enrollment: 29
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ReSTOR Toric	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This study is a prospective, single center, open clinical trial to collect normative performance data.This study is a prospective, single center, open clinical trial to collect normative performance data.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
• Actual Study Start Date: Oct 5, 2018
• Actual Primary Completion Date: Nov 18, 2019
• Actual Study Completion Date: Nov 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Toric 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. Patients will self-select for multifocal implantation.	Device: ReSTOR Toric; ReSTOR Toric bilateral IOL implantation; Other Names: ReSTOR +2.5 Toric ReSTOR +3.0 Toric

Outcome Measures

Primary Outcome Measures

1. Residual Refractive Cylinder [3 months]

   Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation

Secondary Outcome Measures

1. Monocular Uncorrected Near Visual Acuity [3 months]

   Monocular uncorrected near visual acuity measuring in logMAR

2. Monocular Uncorrected Distance Visual Acuity [3 months]

   Monocular uncorrected distance visual acuity measured in logMAR notation

3. Monocular Uncorrected Intermediate Visual Acuity [3 months]

   Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)

4. Monocular Best Corrected Distance Visual Acuity [3 months]

   Monocular best corrected distance visual acuity measured in logMAR notation

5. Monocular Best Distance-corrected Intermediate Visual Acuity [3 months]

   Monocular best distance-corrected intermediate visual acuity in logMAR notation

6. Monocular Best Distance-corrected Near Visual Acuity [3 months]

   Monocular best distance-corrected near visual acuity measured in logMAR notation

7. Binocular Uncorrected Near Visual Acuity [3 months]

   Binocular uncorrected near (40cm) visual acuity measured in logMAR notation

8. Binocular Uncorrected Distance Visual Acuity [3 months]

   Binocular uncorrected distance visual acuity measured in logMAR notation

9. Binocular Uncorrected Intermediate Visual Acuity [3 months]

   Binocular uncorrected intermediate (60cm) visual acuity

10. Binocular Best-corrected Distance Visual Acuity [3 months]

    Binocular best-corrected distance visual acuity measured in logMAR notation

11. Binocular Best Distance-corrected Intermediate Visual Acuity [3 months]

    Binocular best distance-corrected intermediate (60cm) visual acuity

12. Binocular Best Distance-corrected Near Visual Acuity [3 months]

    Binocular best distance-corrected near (40cm) visual acuity

13. IOL Orientation [3 months]

    Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.

14. Binocular Best Distance-corrected Defocus Curve [3 months]

    Binocular best distance-corrected defocus curve.

15. Binocular Uncorrected Defocus Curve. [3 months]

    Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments

16. Subjective Visual Quality [3 months]

    Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

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
• SiV Consulting

Investigators

• Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 20, 2018

More Information

Publications

None provided.

• Responsible Party: Clayton Blehm, MD, Principal investigator, Gainesville Eye Associates
• ClinicalTrials.gov Identifier: NCT03856944
• Other Study ID Numbers: CB-18-001
• First Posted: Feb 27, 2019
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Clayton Blehm, MD, Principal investigator, Gainesville Eye Associates: Astigmatism; intraocular lens; multifocal
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Period Title: Overall Study
STARTED	29
COMPLETED	29
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (9)
Sex: Female, Male (Count of Participants)
Female	18 62.1%
Male	11 37.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Residual Refractive Cylinder
Description	Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [diopters]	0.02 (0.08)

2. Secondary Outcome

Title	Monocular Uncorrected Near Visual Acuity
Description	Monocular uncorrected near visual acuity measuring in logMAR
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.12 (0.11)

3. Secondary Outcome

Title	Monocular Uncorrected Distance Visual Acuity
Description	Monocular uncorrected distance visual acuity measured in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.04 (0.09)

4. Secondary Outcome

Title	Monocular Uncorrected Intermediate Visual Acuity
Description	Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.06 (0.11)

5. Secondary Outcome

Title	Monocular Best Corrected Distance Visual Acuity
Description	Monocular best corrected distance visual acuity measured in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	.04 (.09)

6. Secondary Outcome

Title	Monocular Best Distance-corrected Intermediate Visual Acuity
Description	Monocular best distance-corrected intermediate visual acuity in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	.06 (.11)

7. Secondary Outcome

Title	Monocular Best Distance-corrected Near Visual Acuity
Description	Monocular best distance-corrected near visual acuity measured in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	.11 (0.12)

8. Secondary Outcome

Title	Binocular Uncorrected Near Visual Acuity
Description	Binocular uncorrected near (40cm) visual acuity measured in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.01 (0.08)

9. Secondary Outcome

Title	Binocular Uncorrected Distance Visual Acuity
Description	Binocular uncorrected distance visual acuity measured in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	-0.01 (0.07)

10. Secondary Outcome

Title	Binocular Uncorrected Intermediate Visual Acuity
Description	Binocular uncorrected intermediate (60cm) visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	-0.02 (0.07)

11. Secondary Outcome

Title	Binocular Best-corrected Distance Visual Acuity
Description	Binocular best-corrected distance visual acuity measured in logMAR notation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	-0.03 (0.05)

12. Secondary Outcome

Title	Binocular Best Distance-corrected Intermediate Visual Acuity
Description	Binocular best distance-corrected intermediate (60cm) visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	-0.06 (0.03)

13. Secondary Outcome

Title	Binocular Best Distance-corrected Near Visual Acuity
Description	Binocular best distance-corrected near (40cm) visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.01 (0.01)

14. Secondary Outcome

Title	IOL Orientation
Description	Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Subjects are enrolled, eyes (2x subjects) were evaluated for some tests.

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Measure Eyes	58
Number [Eyes with < 5 degrees rot'n from 1-3 mos]	56

15. Secondary Outcome

Title	Binocular Best Distance-corrected Defocus Curve
Description	Binocular best distance-corrected defocus curve.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Defocus +1.00	.24 (.20)
Defocus +0.50	.07 (.11)
Defocus 0.00	-.01 (0.07)
Defocus -4.00	.55 (.19)
Defocus -3.50	.40 (.15)
Defocus -3.00	.28 (.12)
Defocus -2.50	.19 (.11)
Defocus -2.00	.16 (.11)
Defocus -1.50	.21 (.11)
Defocus -1.00	.19 (.08)
Defocus -0.50	0.08 (0.10)

16. Secondary Outcome

Title	Binocular Uncorrected Defocus Curve.
Description	Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	27
Defocus 1.00	.22 (.20)
Defocus 0.50	.07 (.11)
Defocus 0.00	-.01 (.08)
Defocus -4.00	.55 (.19)
Defocus -3.50	.41 (.16)
Defocus -3.00	.29 (0.13)
Defocus -2.50	.18 (.11)
Defocus -2.00	.16 (.11)
Defocus -1.50	.20 (.11)
Defocus -1.00	.19 (.08)
Defocus -0.50	0.09 (.10)

17. Secondary Outcome

Title	Subjective Visual Quality
Description	Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Measure Participants	29
Frequency	32
Severity	22
Degree of Bother	0

Adverse Events

Time Frame	3 months
Arm/Group Title	ReSTOR Toric
Arm/Group Description	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. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
All Cause Mortality
	ReSTOR Toric
	Affected / at Risk (%)	# Events
Total	0/29 (0%)
Serious Adverse Events
	ReSTOR Toric
	Affected / at Risk (%)	# Events
Total	0/29 (0%)
Other (Not Including Serious) Adverse Events
	ReSTOR Toric
	Affected / at Risk (%)	# Events
Total	0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.