Performance and Acceptability of iDesign

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01220466
• Collaborator: (none)
• Enrollment: 77
• Locations: 4
• Arm: 1
• Duration (Months): 14
• Patients Per Site: 19.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The results of this trial will demonstrate that the iDesign System performs as intended and is acceptable in a clinical setting.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: STAR S4IR LASIK with iDesign Aberrometer	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: 77 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 the iDesign Advanced WaveScan Study(tm) System
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Refractive Error	Device: STAR S4IR LASIK with iDesign Aberrometer; CustomVue LASIK targeted for emmetropia; Other Names: CustomVue

Outcome Measures

Primary Outcome Measures

1. Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better. [6 months]

Other Outcome Measures

1. Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D [6 months]

2. Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) [6 Months]

3. Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40 [6 Months]

4. Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction [6 Months]

   Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, of any race, and at least 18 years old at the time the consent form is signed.

• The refractive error, based on manifest refraction (adjusted for optical infinity), must be MRSE up to -15.00 D with manifest cylinder between 0.00 and -6.00 D; MRSE up to +9.00 D with cylinder between 0.00 and +6.00 D; or manifest cylinder (from 1.00 to 6.00 D) greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.

• BSCVA of 20/20 or better.

• UCVA:

• Myopes must be 20/40 or worse.

• Subjects with Hyperopia or mixed astigmatism, treatment may be based on difficulty maintaining UCVA of 20/40 evidenced by spectacle/contact lens dependence for distance, as documented by the investigator.

• Wavefront diameter ≥ 4.0 mm.

• Sufficient agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction (sphere, cylinder, and axis) to allow treatment selection and generation of an ablation profile as determined by the investigational iDesign System software.

• Manifest refraction sphere within ± 0.75 D of cycloplegic refraction sphere.

• 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 (as calculated by the iDesign System) and the intended flap thickness.

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

• A stable refractive error (based on a previous exam, medical records, or prescription) as compared to the unadjusted pre-operative manifest refraction.

• Subjects who currently wear contact lenses must demonstrate refractive stability in the operative eye. Rigid or toric lenses must be removed for at least 2 weeks and SCL for at least 3 days prior to the first refraction used to establish stability. A second refraction with a change of no more than ± 0.50 D MRSE at least 7 days after baseline.

• Willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria:

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry, or another condition associated with the fluctuation of hormones that could lead to refractive changes.

• Subjects with an ametropic or amblyopic fellow eye not meeting all inclusion criteria that does not fall within the indications for treatment using the VISX® STAR S4 IR™ Excimer Laser.

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

• Acute or chronic disease, illness, or treatment that would increase the operative risk (e.g., immuno-compromised, autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes, etc.).

• Subjects with a cardiac pacemaker, implanted defibrillator, implanted neurostimulator, or any active electrical implants.

• Ocular condition (other than high myopia) that may predispose the subject to future complications, such as history or evidence of active or inactive corneal disease

• Previous intraocular or corneal surgery that might confound the outcome of the study or increase risk to the subject.

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

• Concurrent participation in any other clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clearly LASIK	Victoria	British Columbia	Canada	V8X 1X2
2	Image Plus Laser Eye Center	Winnipeg	Manitoba	Canada	R3C 3J5
3	University of Ottawa Eye Institute, The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
4	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: NCT01220466
• Other Study ID Numbers: STAR-108-IDSN
• First Posted: Oct 14, 2010
• Last Update Posted: May 20, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	One or both eyes of 77 subjects (143 eyes) were treated. This includes a predominance of Caucasian participants and a mean age of 37.2 years.

Arm/Group Title	Hyperopia With or Without Astigmatism	Myopia With or Without Astigmatism	Mixed Astigmatism
Arm/Group Description	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Myopia with and without astigmatism with MRSE up to -15.0D, 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	11	56	10
COMPLETED	11	56	10
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Hyperopia With or Without Astigmatism	Myopia With or Without Astigmatism	Mixed Astigmatism	Total
Arm/Group Description	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.	Myopia with and without astigmatism with MRSE up to -15.0D, 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	11	56	10	77
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	11 100%	56 100%	10 100%	77 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	6 54.5%	28 50%	4 40%	38 49.4%
Male	5 45.5%	28 50%	6 60%	39 50.6%
Region of Enrollment (participants) [Number]
Canada	11 100%	56 100%	10 100%	77 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better

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 -15.0 D, 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	56	11	10
Measure eyes	108	19	16
Number (95% Confidence Interval) [percentage of eyes]	100	100	100

2. Other Pre-specified Outcome

Title	Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D

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 -15.0 D, 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	56	11	10
Measure eyes	108	19	16
Number (95% Confidence Interval) [percentage of eyes]	99.1	89.5	93.8

3. Other Pre-specified Outcome

Title	Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Percent of eyes that lost more than 2 lines of BSCVA.

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 -15.0 D, 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	56	11	10
Measure eyes	108	19	16
Number (95% Confidence Interval) [percentage of eyes]	0	5.3	0

4. Other Pre-specified Outcome

Title	Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Percentage of eyes with BSCVA worse than 20/40

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 -15.0 D, 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	56	11	10
Measure eyes	108	19	16
Number (95% Confidence Interval) [percentage of eyes]	0	0	0

5. Other Pre-specified Outcome

Title	Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction
Description	Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power

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 -15.0 D, 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	56	11	10
Measure eyes	108	19	16
Number (95% Confidence Interval) [percentage of eyes]	0	0	0

Adverse Events

Arm/Group Title	Hyperopia With and Without Astigmatism		Myopia With and Without Astigmatism		Mixed Astigmatism
Arm/Group Description	Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D		Myopia with and without astigmatism with MRSE up to -15.0 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
	Hyperopia With and Without Astigmatism		Myopia 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
	Hyperopia With and Without Astigmatism		Myopia With and Without Astigmatism		Mixed Astigmatism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		2/56 (3.6%)		0/10 (0%)
Eye disorders
Decrease in BSCVA of greater than or equal to two lines	1/11 (9.1%)	1	2/56 (3.6%)	2	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Hyperopia With and Without Astigmatism		Myopia With and Without Astigmatism		Mixed Astigmatism
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/11 (18.2%)		4/56 (7.1%)		0/10 (0%)
Eye disorders
Corneal epithelial defect	1/11 (9.1%)	1	0/56 (0%)	0	0/10 (0%)	0
Foreign body in the eye	0/11 (0%)	0	1/56 (1.8%)	1	0/10 (0%)	0
Miscreated flap	0/11 (0%)	0	1/56 (1.8%)	1	0/10 (0%)	0
retinal tear/hole	0/11 (0%)	0	1/56 (1.8%)	2	0/10 (0%)	0
Injury, poisoning and procedural complications
Other - car accident	1/11 (9.1%)	1	0/56 (0%)	0	0/10 (0%)	0
Other - concussion	0/11 (0%)	0	1/56 (1.8%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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