Performance and Acceptability of VSS-R

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01067716
• Collaborator: (none)
• Enrollment: 150
• Locations: 5
• Arm: 1
• Duration (Months): 24.9
• Patients Per Site: 30
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The results of this trial will demonstrate that AVSS software performs as intended and is acceptable in a clinical setting.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: STAR S4IR LASIK with VSS-R ablation profile	N/A

Detailed Description

LASIK treatment across the range of myopia with or without astigmatism, hyperopia with or without astigmatism, and mixed astigmatism.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study to Evaluate the Performance and Acceptability of Advanced Variable Spot Scanning (AVSS) Ablations With the STAR S4 IR® Excimer Laser System
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Refractive Error	Device: STAR S4IR LASIK with VSS-R ablation profile; LASIK treatment targeted for emmetropia

Outcome Measures

Primary Outcome Measures

1. Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better [1 Year]

Other Outcome Measures

1. Percent Manifest Refraction Spherical Equivalent Within 1.0D [1 Year]

   Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.

2. Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [1 Year]

   After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).

3. Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power [1 Year]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female, of any race, and at least 21 years old at the time of the pre-operative examination and signing the consent form.

• The refractive error, based on manifest refraction at the spectacle plane, of: MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +7.00 D, with manifest cylinder between 0.00 and 6.00 D; or Manifest cylinder (from 1.0 to 6.0 D) greater than the magnitude of sphere, and the manifest cylinder and sphere have opposite signs.

• BSCVA of 20/20 or better.

• UCVA of 20/40 or worse.

• Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere (at the same vertex distance).

• Anticipated post-operative stromal bed thickness of at least 250 microns, based on pre-operative central corneal pachymetry minus the maximum treatment depth to be ablated and the intended flap thickness, and confirmed by intra-operative central corneal pachymetry.

• Anticipated post-operative keratometry value (based on pre-operative manifest refraction and keratometry) that is appropriate.

• A stable refractive error, based on an exam (or prescription) at least 12 months prior to the pre-operative examination and as compared to the pre-operative manifest refraction

• Subjects who have worn a contact lens in the operative eye must discontinue lens wear at least three (3) consecutive weeks prior to the pre-operative examination. If, upon review of pre-operative measurements, the Investigator determines that the corneal topography is within normal limits, surgery may be scheduled (within 60 days), with no contact lens wear permitted prior to the surgery.

• Willing and capable of returning for follow-up examinations for the duration of the study (6 months).

Exclusion Criteria:

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry.

• Concurrent use of topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.

• History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

• Subjects with a cardiac pacemaker or implanted defibrillator.

• History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.

• Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal videokeratography.

• Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.

• Subjects with one eye that does not meet all inclusion criteria and does not fall within approved indications for treatment using the VISX® STAR S4 IR® Excimer Laser.

• Participation in any other clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Laser Eye Centre	Abbottsford	British Columbia	Canada	V2S 3R1
2	Clearly LASIK	Victoria	British Columbia	Canada	V8X 1X2
3	Image Plus Laser Eye Center	Winnipeg	Manitoba	Canada	R3C 3J5
4	University of Ottawa Eye Institute	Ottawa	Ontario	Canada	K1H 8LB
5	Yonge-Eglington Laser	Toronto	Ontario	Canada	M4P 2E5

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Study Director: Nicholas Tarantino, OD, Abbott Medical Optics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT01067716
• Other Study ID Numbers: STAR-107-AVSS
• First Posted: Feb 12, 2010
• Last Update Posted: Oct 31, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	One or both eyes of 79 subjects (150 eyes) were treated.

Arm/Group Title	Myopia With and Without Astigmatism	Hyperopia With and Without Astigmatism	Mixed Astigmatism
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
Period Title: Overall Study
STARTED	57	13	9
COMPLETED	57	13	9
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Myopia With or Without Astigmatism	Hyperopia With and Without Astigmatism	Mixed Astigmatism	Total
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.	Total of all reporting groups
Overall Participants	57	13	9	79
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	57 100%	13 100%	9 100%	79 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	25 43.9%	9 69.2%	4 44.4%	38 48.1%
Male	32 56.1%	4 30.8%	5 55.6%	41 51.9%
Region of Enrollment (participants) [Number]
Canada	57 100%	13 100%	9 100%	79 100%

Outcome Measures

1. Primary Outcome

Title	Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.

Arm/Group Title	Myopia With and Without Astigmatism	Hyperopia With and Without Astigmatism	Mixed Astigmatism
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
Measure Participants	57	13	9
Measure eyes	110	25	15
Number (95% Confidence Interval) [percentage of eyes]	99.1	96.0	100.0

2. Other Pre-specified Outcome

Title	Percent Manifest Refraction Spherical Equivalent Within 1.0D
Description	Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.

Arm/Group Title	Myopia With and Without Astigmatism	Hyperopia With and Without Astigmatism	Mixed Astigmatism
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
Measure Participants	57	13	9
Measure eyes	110	25	15
Number (95% Confidence Interval) [percentage of eyes]	96.4	92.0	100.0

3. Other Pre-specified Outcome

Title	Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Description	After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myopia With and Without Astigmatism	Hyperopia With and Without Astigmatism	Mixed Astigmatism
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
Measure Participants	57	13	9
Measure eyes	110	25	15
Number (95% Confidence Interval) [percentage of eyes]	.9	4.0	0.0

4. Other Pre-specified Outcome

Title	Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myopia With and Without Astigmatism	Hyperopia With and Without Astigmatism	Mixed Astigmatism
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
Measure Participants	57	13	9
Measure eyes	110	25	15
Number (95% Confidence Interval) [percentage of eyes]	0.0	0.0	0.0

Adverse Events

Time Frame	1 year
Arm/Group Title	Myopia With or Without Astigmatism		Hyperopia With and Without Astigmatism		Mixed Astigmatism
Arm/Group Description	Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.		Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.		Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
All Cause Mortality
	Myopia With or Without Astigmatism		Hyperopia With and Without Astigmatism		Mixed Astigmatism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Myopia With or Without Astigmatism		Hyperopia With and Without Astigmatism		Mixed Astigmatism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		1/13 (7.7%)		0/9 (0%)
Eye disorders
Decrease in BSCVA of greater than or equal to two lines	0/57 (0%)	0	1/13 (7.7%)	1	0/9 (0%)	0
Other (Not Including Serious) Adverse Events
	Myopia With or Without Astigmatism		Hyperopia With and Without Astigmatism		Mixed Astigmatism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/57 (29.8%)		12/13 (92.3%)		0/9 (0%)
Eye disorders
Inadvertent insallation of Tropicamide instead of Tetracaine	0/57 (0%)	0	1/13 (7.7%)	1	0/9 (0%)	0
Elevated IOP (temporary)	2/57 (3.5%)	2	0/13 (0%)	0	0/9 (0%)	0
Photic phenomena (i.e., halos, glare, starbursts)	9/57 (15.8%)	9	2/13 (15.4%)	2	0/9 (0%)	0
Corneal Haze	0/57 (0%)	0	1/13 (7.7%)	1	0/9 (0%)	0
Dry eye	4/57 (7%)	4	5/13 (38.5%)	5	0/9 (0%)	0
Double vision	0/57 (0%)	0	1/13 (7.7%)	1	0/9 (0%)	0
Superficial epithelial linear laceration	0/57 (0%)	0	1/13 (7.7%)	1	0/9 (0%)	0
Peripheral infiltrates	1/57 (1.8%)	1	0/13 (0%)	0	0/9 (0%)	0
General disorders
Other - cold/flu	1/57 (1.8%)	1	0/13 (0%)	0	0/9 (0%)	0
Injury, poisoning and procedural complications
Other - hairline ankle fracture	0/57 (0%)	0	1/13 (7.7%)	1	0/9 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

At least ninety (90) days prior to any proposed submission for publication or presentation of Study Data or other findings related to the Study, Institution will provide Sponsor with a manuscript of such submission(s) for review, comment, and approval. For greater certainty, neither Institution nor Principal Investigator shall have any right to publish any information or results concerning the Study without the express written consent of Sponsor.