Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
Study Details
Study Description
Brief Summary
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: wave-front guided LASIK
|
Device: LASIK
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System
|
Outcome Measures
Primary Outcome Measures
- Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) [3 Months]
< 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
- Uncorrected Visual Acuity (UCVA) of 20/40 or Better [3 Months]
85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Eligibility Criteria
Criteria
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 lest 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 | Univerisity of Miami Bascom Palmer Eye Institute | Miami | Florida | United States | 33136 |
| 2 | Kraff Eye Institute | Chicago | Illinois | United States | 60602 |
| 3 | Pepose Vision Institute | Chesterfield | Missouri | United States | 63017-5065 |
| 4 | Durrie Vision | Kansas City | Missouri | United States | 66211 |
| 5 | Coleman Vision | Albuquerque | New Mexico | United States | 87109 |
| 6 | Lehmann Eye Center | Nacogdoches | Texas | United States | 75965 |
| 7 | The Eye Center | Fairfax | Virginia | United States | 22031 |
| 8 | King LASIK | Renton | Washington | United States | 98057 |
Sponsors and Collaborators
- Abbott Medical Optics
Investigators
- Study Director: Kendra Hileman, PhD, Abbott Medical Optics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STAR-112-IDMA
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Wave-front Guided LASIK |
|---|---|
| Arm/Group Description | Vision correction for a mixed astigmatism refraction |
| Period Title: Overall Study | |
| STARTED | 84 |
| COMPLETED | 42 |
| NOT COMPLETED | 42 |
Baseline Characteristics
| Arm/Group Title | Wave-front Guided LASIK |
|---|---|
| Arm/Group Description | LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction |
| Overall Participants | 84 |
| Overall eyes | 149 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
36.3
(10.36)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
39
46.4%
|
| Male |
45
53.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
1.2%
|
| Asian |
2
2.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
6%
|
| White |
73
86.9%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
3.6%
|
| Region of Enrollment (Count of Participants) | |
| United States |
84
100%
|
Outcome Measures
| Title | Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) |
|---|---|
| Description | < 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 | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Wave-front Guided LASIK |
|---|---|
| Arm/Group Description | LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction |
| Measure Participants | 84 |
| Measure eyes | 149 |
| Count of Units [eyes] |
149
|
| Title | Uncorrected Visual Acuity (UCVA) of 20/40 or Better |
|---|---|
| Description | 85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Wave-front Guided LASIK |
|---|---|
| Arm/Group Description | LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction |
| Measure Participants | 84 |
| Measure eyes | 149 |
| Count of Units [eyes] |
149
|
Adverse Events
| Time Frame | 3 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Wave-front Guided LASIK | |
| Arm/Group Description | LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction | |
All Cause Mortality |
||
| Wave-front Guided LASIK | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | |
Serious Adverse Events |
||
| Wave-front Guided LASIK | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Wave-front Guided LASIK | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | |
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Director, Clinical Operations |
|---|---|
| Organization | Abbott Medical Optics |
| Phone | 714-247-8628 |
| lachelle.arredondo@abbott.com |
- STAR-112-IDMA