Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01675479
• Collaborator: (none)
• Enrollment: 167
• Locations: 9
• Arm: 1
• Actual Duration (Months): 46
• Patients Per Site: 18.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

Condition or Disease	Intervention/Treatment	Phase
Hyperopia	Device: LASIK correction of hyperopic refractive errors	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System
• Actual Study Start Date: Dec 31, 2012
• Actual Primary Completion Date: Oct 31, 2016
• Actual Study Completion Date: Oct 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: wavefront-guided LASIK	Device: LASIK correction of hyperopic refractive errors; Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

Outcome Measures

Primary Outcome Measures

1. Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) [12 Months]

   Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Secondary Outcome Measures

1. Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better [12 Months]

   Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• At least 18 years of age at the time of pre-operative exam

• Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better

• Demonstration of refractive stability

• Anticipated post-operative stromal bed thickness of at least 250 microns

• 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

• Concurrent use of topical or systemic medications that may impair healing

• History of any medical conditions that could affect wound healing

• History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality

• Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maloney Vision Institute	Los Angeles	California	United States	90024
2	University of Miami Bascom Palmer Eye Institute	Miami	Florida	United States	33136
3	Kraff Eye Institute	Chicago	Illinois	United States	60602
4	Pepose Vision Institute	Chesterfield	Missouri	United States	63017
5	Durrie Vision	Kansas City	Missouri	United States	66211
6	Coleman Vision	Albuquerque	New Mexico	United States	87109
7	Lehmann Eye Center	Nacogdoches	Texas	United States	75965
8	The Eye Center	Fairfax	Virginia	United States	22031
9	King LASIK	Renton	Washington	United States	98057

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT01675479
• Other Study ID Numbers: STAR-111-IDHP
• First Posted: Aug 30, 2012
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 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 Abbott Medical Optics: refractive; errors
• Additional relevant MeSH terms: Refractive Errors; Hyperopia

Study Results

Participant Flow

Pre-assignment Detail	167 subjects were consented in the study, of which 69 subjects had one or both eyes treated for a total of 135 treated eyes.

Arm/Group Title	Wavefront-Guided LASIK
Arm/Group Description	LASIK correction of hyperopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Period Title: Overall Study
STARTED	69
COMPLETED	58
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Wavefront-Guided LASIK
Arm/Group Description	LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Overall Participants	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.7 (11.8)
Sex: Female, Male (Count of Participants)
Female	35 50.7%
Male	34 49.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 5.8%
White	58 84.1%
More than one race	0 0%
Unknown or Not Reported	6 8.7%
Region of Enrollment (Count of Participants)
United States	69 100%

Outcome Measures

1. Primary Outcome

Title	Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Description	Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wavefront-Guided LASIK
Arm/Group Description	LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Measure Participants	67
Measure eyes	131
Count of Units [eyes]	2

2. Secondary Outcome

Title	Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better
Description	Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wavefront-Guided LASIK
Arm/Group Description	LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Measure Participants	67
Measure eyes	131
Count of Units [eyes]	123

Adverse Events

Time Frame	24 months
Arm/Group Title	Wavefront-Guided LASIK
Arm/Group Description	LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
All Cause Mortality
	Wavefront-Guided LASIK
	Affected / at Risk (%)	# Events
Total	0/69 (0%)
Serious Adverse Events
	Wavefront-Guided LASIK
	Affected / at Risk (%)	# Events
Total	3/69 (4.3%)
Eye disorders
Epithelial ingrowth requiring non refractive intervention	1/69 (1.4%)
Decrease in BSCVA	1/69 (1.4%)
Cataract	1/69 (1.4%)
Severe glare	1/69 (1.4%)
Other (Not Including Serious) Adverse Events
	Wavefront-Guided LASIK
	Affected / at Risk (%)	# Events
Total	0/69 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.