Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

Myopia Clinical Trial

Official title:

Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575911
• Other study ID #: CTJ121-P001
• Status: Completed
• Phase: N/A
• Start date: October 28, 2015
• Est. completion date: April 9, 2016

Study information

• Verified date: April 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 9, 2016
• Est. primary completion date: April 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Femtosecond Laser System
Used for the creation of a corneal flap in patients undergoing LASIK surgery

Procedure:
• LASIK surgery

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative	Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.	Month 3 postoperative
Secondary	Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative	Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.	Month 1 postoperative
Secondary	Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative	Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.	Month 1, Month 3 postoperative
Secondary	Ease of Flap Dissection at Day 0, Operative Day	Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.	Day 0, operative day
Secondary	Stromal Bed Quality at Day 0, Operative Day	Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.	Day 0, operative day
Secondary	Opaque Bubble Layer (OBL) at Day 0, Operative Day	Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.	Day 0, operative day
Secondary	Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative	UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.	Month 1, Month 3 postoperative
Secondary	Best Corrected Distance Visual Acuity (BCDVA) by Visit	BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.	Baseline, Month 1, Month 3 postoperative
Secondary	Manifest Refraction Spherical Equivalent (MRSE)	The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.	Baseline, Month 1, Month 3 postoperative
Secondary	Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op	Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative	Month 1, Month 3 postoperative

External Links

•   Results from the Novartis Clinical Trial Results Website