Clinical trial NCT02575911: Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Official title: Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 34
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
* Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
* If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
* Willing and able to return for ALL scheduled follow-up examinations;
* Willing and able to provide written informed consent;
* Eligible for bilateral LASIK procedures to be done on the same day;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
* Known sensitivity to planned study concomitant medications;
* Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
* Irregular astigmatism, based on the Investigator's judgement;
* Pregnant, lactating or planning to become pregnant during the course of the study;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
timeFrame: Month 3 postoperative
Secondary outcomes:
measure: Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative
timeFrame: Month 1 postoperative
measure: Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative
timeFrame: Month 1, Month 3 postoperative
measure: Ease of Flap Dissection at Day 0, Operative Day
timeFrame: Day 0, operative day
measure: Stromal Bed Quality at Day 0, Operative Day
timeFrame: Day 0, operative day
measure: Opaque Bubble Layer (OBL) at Day 0, Operative Day
timeFrame: Day 0, operative day
measure: Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative
timeFrame: Month 1, Month 3 postoperative
measure: Best Corrected Distance Visual Acuity (BCDVA) by Visit
timeFrame: Baseline, Month 1, Month 3 postoperative
measure: Manifest Refraction Spherical Equivalent (MRSE)
timeFrame: Baseline, Month 1, Month 3 postoperative
measure: Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
timeFrame: Month 1, Month 3 postoperative
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Trial Manager, GCRA
role: STUDY_DIRECTOR
References: