Trial Outcomes & Findings for New Treatment Algorithm to Reduce Spherical Aberration After LASIK Correction for Myopia (NCT NCT01988415)

NCT ID: NCT01988415

Last Updated: 2016-02-05

Results Overview

Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2016-02-05

Participant Flow

Participant milestones

Measure	VSS-Rx1 OPM vs Commercial iDesign Treatment Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator \[i.e., control\]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Treatment Algorithm to Reduce Spherical Aberration After LASIK Correction for Myopia

Baseline characteristics by cohort

Measure	VSS-Rx1 OPM vs Commercial iDesign Treatment n=26 Participants Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator \[i.e., control\]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
Age, Continuous	29 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Colombia	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The analysis population was all evaluable eyes.

Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.

Outcome measures

Measure	Commercial iDesign Treatment Planning Software n=26 Eyes Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software	VSS-Rx1 OPM Treatment Planning Software n=26 Eyes Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
Mean Postoperative Spherical Aberration	0.069 µm Standard Deviation 0.092	0.016 µm Standard Deviation 0.108

PRIMARY outcome

Timeframe: 3 Months

Population: The analysis population was all evaluable eyes.

Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity

Outcome measures

Measure	Commercial iDesign Treatment Planning Software n=26 Eyes Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software	VSS-Rx1 OPM Treatment Planning Software n=26 Eyes Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity	0 percentage of eyes	0 percentage of eyes

Adverse Events

Commercial iDesign Treatment Planning Software

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VSS-Rx1 OPM Treatment Planning Software

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janice Tarrant

Abbott Medical Optics

Phone: 408-273-4163

Email: janice.tarrant@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor shall have the first right of publication of study data for the first 12 months. The institution or principal investigator may not disclose any of the Sponsor's proprietary information.
• Publication restrictions are in place

Restriction type: OTHER