Hyperopia, Hyperopic Astigmatism
Conditions
Keywords
LASIK, Refractive errors
Brief summary
The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.
Detailed description
Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.
Interventions
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
PROCEDURELASIK
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Intended to treat bilaterally; * Hyperopia with or without astigmatism as specified in the protocol; * Stable vision as specified in the protocol; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Glaucoma; * Cataracts; * Previous eye surgery; * Intent to have monovision treatment; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability | Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12) | A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis. |
| Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability | Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12) | A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis. |
| Percentage of Eyes Experiencing Ocular Adverse Events (AEs) | Up to Month 12 postoperative | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 5 investigative sites located in 1 country (US).
Pre-assignment details
Of the 44 enrolled, 14 participants were discontinued as screen failures prior to attempted surgery. This reporting group includes all enrolled participants/eyes with attempted surgery (30/60, respectively).
Participants by arm
| Arm | Count |
|---|---|
| WaveLight EX500 Excimer Laser System Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | WaveLight EX500 Excimer Laser System |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 10.42 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 26 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 29 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 60 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 10 / 60 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 2 / 60 | 0 / 30 |
Outcome results
Primary
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.
Time frame: Up to Month 12 postoperative
Population: Safety Analysis Set: all eyes for which refractive surgery was attempted with the test device (regardless of success or failure).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes Experiencing Ocular Adverse Events (AEs) | Diplopia | 11.7 percentage of eyes |
| WaveLight EX500 Excimer Laser System | Percentage of Eyes Experiencing Ocular Adverse Events (AEs) | Photophobia | 6.7 percentage of eyes |
| WaveLight EX500 Excimer Laser System | Percentage of Eyes Experiencing Ocular Adverse Events (AEs) | Visual acuity reduced | 3.3 percentage of eyes |
| WaveLight EX500 Excimer Laser System | Percentage of Eyes Experiencing Ocular Adverse Events (AEs) | Ocular hyperaemia | 1.7 percentage of eyes |
Primary
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.
Time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Population: Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability | 98.3 percentage of eyes |
p-value: <0.0001Exact Test of Binomial Proportion
Primary
Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.
Time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Population: Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WaveLight EX500 Excimer Laser System | Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability | 100.0 percentage of eyes |
p-value: <0.0001Exact Test of Binomial Proportion