Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01200511
• Collaborator: (none)
• Enrollment: 49
• Arm: 1
• Duration (Months): 13

Study Details

Study Description

Brief Summary

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL	N/A

Detailed Description

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR +3.0 AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	Device: AcrySof® IQ ReSTOR® +3.0 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: Models SND1T3, SND1T4, SND1T5

Outcome Measures

Primary Outcome Measures

1. Uncorrected Visual Acuity Across a Range of Distances at Month 6 [Month 6 from second eye implantation]

   Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.

2. Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 [Month 6 from second eye implantation]

   VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.

3. Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 [Month 6 from second eye implantation]

   Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.

Secondary Outcome Measures

1. Patient Reported Outcomes at Month 6 [Month 6 from second eye implantation]

   The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign informed consent;

• Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;

• Able to undergo second eye surgery within one month (30 days) of first eye surgery;

• Able to attend postoperative examinations per protocol schedule;

• Qualify for a AcrySof IQ Toric IOL in both eyes;

• Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;

• Residual refractive cylinder of ≤0.5 D in both eyes;

• Good ocular health;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;

• Amblyopia;

• Previous corneal surgery;

• Clinically significant corneal endothelial dystrophy;

• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);

• History of retinal detachment;

• Pregnant or planning to become pregnant during course of study;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Brand Lead, Surgical, Global Medical Affairs, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01200511
• Other Study ID Numbers: M09-052
• First Posted: Sep 13, 2010
• Last Update Posted: Jul 2, 2018
• Last Verified: Mar 1, 2017

• Keywords provided by Alcon Research: intraocular lens; multifocal; toric
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 investigational sites located in Germany (2), Venezuela (2), and Spain (1).
Pre-assignment Detail	This reporting population includes all enrolled subjects.

Arm/Group Title	ReSTOR +3.0 Toric
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Period Title: Overall Study
STARTED	49
COMPLETED	44
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	ReSTOR +3.0 Toric
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Participants	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.52 (7.49)
Sex: Female, Male (Count of Participants)
Female	30 68.2%
Male	14 31.8%

Outcome Measures

1. Primary Outcome

Title	Uncorrected Visual Acuity Across a Range of Distances at Month 6
Description	Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Time Frame	Month 6 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Arm/Group Title	ReSTOR +3.0 Toric
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Measure Participants	42
Far distance 4 meters (m)	0.05 (0.10)
Intermediate 70 centimeters (cm)	0.15 (0.13)
Intermediate 60 cm	0.09 (0.11)
Intermediate 50 cm	0.05 (0.09)
Near 40 cm	0.07 (0.09)
Near - preferred	0.04 (0.08)

2. Primary Outcome

Title	Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
Description	VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (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.
Time Frame	Month 6 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Arm/Group Title	ReSTOR +3.0 Toric
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Measure Participants	42
Far distance 4 m	0.00 (0.06)
Intermediate 70 cm	0.19 (0.14)
Intermediate 60 cm	0.14 (0.14)
Intermediate 50 cm	0.06 (0.10)
Near 40 cm	0.04 (0.07)
Near - preferred distance	0.05 (0.08)

3. Primary Outcome

Title	Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Description	Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Time Frame	Month 6 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.

Arm/Group Title	ReSTOR +3.0 Toric
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Measure Participants	44
± 0.5D	84.5 192%
± 0.75D	92.9 211.1%
±1.0D	95.2 216.4%

4. Secondary Outcome

Title	Patient Reported Outcomes at Month 6
Description	The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Time Frame	Month 6 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.

Arm/Group Title	ReSTOR +3.0 Toric/Without	ReSTOR +3.0 Toric/With
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
Measure Participants	44	44
Near function scale score	1.72 (0.65)	1.65 (0.60)
Intermediate function scale score	1.49 (0.59)	1.21 (0.51)
Extended intermediate function scale score	1.24 (0.38)	1.20 (0.37)

Adverse Events

Time Frame	An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship.
Adverse Event Reporting Description	This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
Arm/Group Title	ReSTOR +3.0 Toric
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
All Cause Mortality
	ReSTOR +3.0 Toric
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR +3.0 Toric
	Affected / at Risk (%)	# Events
Total	7/49 (14.3%)
Eye disorders
Macular oedema	1/49 (2%)
Gastrointestinal disorders
Gastrointestinal bleeding	1/49 (2%)
General disorders
Device dislocation	3/49 (6.1%)
Investigations
Intraocular pressure test abnormal	1/49 (2%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/49 (2%)
Surgical and medical procedures
Intraocular Lens Repositioning	3/49 (6.1%)
Other (Not Including Serious) Adverse Events
	ReSTOR +3.0 Toric
	Affected / at Risk (%)	# Events
Total	3/49 (6.1%)
Eye disorders
Posterior capsule opacification	3/49 (6.1%)

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.