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

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01988415
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Device: VSS-Rx1 OPM vs Commercial iDesign Treatment	N/A

Detailed Description

Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator [i.e., control]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: VSS-Rx1 OPM vs Commercial iDesign Treatment Commercially available iDesign treatment planning 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).	Device: VSS-Rx1 OPM vs Commercial iDesign Treatment; Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile vs VSS-Rx1 OPM (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration).

Outcome Measures

Primary Outcome Measures

1. Mean Postoperative Spherical Aberration [3 months]

   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.

2. Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity [3 Months]

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female at least 18 years of age at the time of preoperative exam

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

• Demonstration of refractive stability

• Anticipated postoperative stromal bed thickness of at least 250 microns

• Willing and able to return for all study examinations

Exclusion Criteria:

• 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 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 postoperative course

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustavo Tamayo, M.D.	Bogota Laser, Bogota		Colombia

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Principal Investigator: Gustavo Tamayo, M.D., Medico Oftalmologo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT01988415
• Other Study ID Numbers: STAR-114-SARA
• First Posted: Nov 20, 2013
• Last Update Posted: Feb 5, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Myopia; Astigmatism

Study Results

Participant Flow

Arm/Group Title	VSS-Rx1 OPM vs Commercial iDesign Treatment
Arm/Group Description	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).
Period Title: Overall Study
STARTED	26
COMPLETED	26
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	VSS-Rx1 OPM vs Commercial iDesign Treatment
Arm/Group Description	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 Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29 (6.6)
Sex: Female, Male (Count of Participants)
Female	14 53.8%
Male	12 46.2%
Region of Enrollment (participants) [Number]
Colombia	26 100%

Outcome Measures

1. Primary Outcome

Title	Mean Postoperative Spherical Aberration
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

The analysis population was all evaluable eyes.

Arm/Group Title	Commercial iDesign Treatment Planning Software	VSS-Rx1 OPM Treatment Planning Software
Arm/Group Description	Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software	Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
Measure Participants	26	26
Measure Eyes	26	26
Mean (Standard Deviation) [µm]	0.069 (0.092)	0.016 (0.108)

2. Primary Outcome

Title	Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity
Description	Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

The analysis population was all evaluable eyes.

Arm/Group Title	Commercial iDesign Treatment Planning Software	VSS-Rx1 OPM Treatment Planning Software
Arm/Group Description	Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software	Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
Measure Participants	26	26
Measure Eyes	26	26
Number [percentage of eyes]	0	0

Adverse Events

Time Frame	3 months
Arm/Group Title	Commercial iDesign Treatment Planning Software		VSS-Rx1 OPM Treatment Planning Software
Arm/Group Description	Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software		Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
All Cause Mortality
	Commercial iDesign Treatment Planning Software		VSS-Rx1 OPM Treatment Planning Software
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Commercial iDesign Treatment Planning Software		VSS-Rx1 OPM Treatment Planning Software
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Commercial iDesign Treatment Planning Software		VSS-Rx1 OPM Treatment Planning Software
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.