Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02176343
• Collaborator: (none)
• Enrollment: 37
• Arm: 1
• Actual Duration (Months): 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Presbyopia; Corneal Astigmatism	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL	N/A

Detailed Description

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
• Actual Study Start Date: Jul 21, 2014
• Actual Primary Completion Date: Aug 22, 2014
• Actual Study Completion Date: Aug 22, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Toric +2.5 AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL; Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient; Other Names: Model SV25T2 Model SV25T3 Model SV25T4 Model SV25T5

Outcome Measures

Primary Outcome Measures

1. Mean Percent Reduction in Cylinder [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.

2. Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

3. Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

4. Mean Uncorrected Distance Visual Acuity [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

5. Mean Uncorrected Near Visual Acuity [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

6. Mean Uncorrected Intermediate Visual Acuity [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

7. Mean Best Corrected Distance Visual Acuity (BCDVA) [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

8. Mean IOL Rotation [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

   Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);

• Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;

• Must complete a visit within 10 days after IOL implantation;

• Successful capsular bag implantation with no surgical complications;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;

• Ocular or intraocular infection or inflammation at the time of the preoperative visit;

• Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;

• Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;

• Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;

• Known history of Type 1 or 2 diabetes for more than 5 years;

• Any ocular or systemic co-morbidity at the preoperative visit;

• Pregnant at the preoperative visit or at the time of Postoperative Visit 2;

• Preoperative corneal astigmatism ≤ 0.50 D;

• Participation in another clinical study at the preoperative visit or at the time of the final study visit;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, GCRA, Surgical, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02176343
• Other Study ID Numbers: C-14-005
• First Posted: Jun 27, 2014
• Last Update Posted: Jul 2, 2018
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Alcon Research: Cataract; Intraocular lens; ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL
• Additional relevant MeSH terms: Cataract; Astigmatism; Presbyopia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 study centers located in Australia.
Pre-assignment Detail	Of the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
Period Title: Overall Study
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Participants	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (9.5)
Sex: Female, Male (Count of Participants)
Female	17 54.8%
Male	14 45.2%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Reduction in Cylinder
Description	Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Mean (Standard Deviation) [percent change]	60.94 (38.17)

2. Primary Outcome

Title	Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
Description	Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Number [percentage of subjects]	67.7

3. Primary Outcome

Title	Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
Description	Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D.

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	12
Number [percentage of subjects]	100.0

4. Primary Outcome

Title	Mean Uncorrected Distance Visual Acuity
Description	Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Mean (Standard Deviation) [logMAR]	0.07 (0.12)

5. Primary Outcome

Title	Mean Uncorrected Near Visual Acuity
Description	VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Mean (Standard Deviation) [logMAR]	0.38 (0.16)

6. Primary Outcome

Title	Mean Uncorrected Intermediate Visual Acuity
Description	VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Mean (Standard Deviation) [logMAR]	0.25 (0.16)

7. Primary Outcome

Title	Mean Best Corrected Distance Visual Acuity (BCDVA)
Description	VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Mean (Standard Deviation) [logMAR]	-0.03 (0.08)

8. Primary Outcome

Title	Mean IOL Rotation
Description	Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.
Time Frame	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Measure Participants	31
Mean (Standard Deviation) [degrees]	3.74 (3.86)

Adverse Events

Time Frame	The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
Adverse Event Reporting Description	An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
Arm/Group Title	ReSTOR Toric +2.5
Arm/Group Description	All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
All Cause Mortality
	ReSTOR Toric +2.5
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Serious Adverse Events
	ReSTOR Toric +2.5
	Affected / at Risk (%)	# Events
Total	3/31 (9.7%)
Eye disorders
Macular oedema	1/31 (3.2%)
Retinal vein occlusion	1/31 (3.2%)
Strabismus	1/31 (3.2%)
Infections and infestations
Staphylococcal infection	1/31 (3.2%)
Surgical and medical procedures
Intra-ocular injection	1/31 (3.2%)
Other (Not Including Serious) Adverse Events
	ReSTOR Toric +2.5
	Affected / at Risk (%)	# Events
Total	4/31 (12.9%)
Eye disorders
Photopsia	2/31 (6.5%)
Surgical and medical procedures
Knee arthroplasty	2/31 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.