An interventional study of WaveLight EX500 excimer laser system and LASIK in Hyperopia and Hyperopic Astigmatism, sponsored by Alcon Research. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
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.
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 125 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
Device: WaveLight EX500 excimer laser system · Procedure: LASIK
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.
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.
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)
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)
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
Participants were recruited from 5 investigative sites located in 1 country (US).
| Milestone | WaveLight EX500 Excimer Laser System |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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 | WaveLight EX500 Excimer Laser System |
|---|---|
| Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability | 98.3 |
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 | WaveLight EX500 Excimer Laser System |
|---|---|
| Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability | 100.0 |
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.
| percentage of eyes | WaveLight EX500 Excimer Laser System |
|---|---|
| Diplopia | 11.7 |
| Photophobia | 6.7 |
| Visual acuity reduced | 3.3 |
| Ocular hyperaemia | 1.7 |
Collected over Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreament | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| WaveLight EX500 Excimer Laser System - Ocular | 0/60 (0%) | 2/60 (3.3%) | 10/60 (16.7%) |
| WaveLight EX500 Excimer Laser System - Systemic | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Event | Pretreament | WaveLight EX500 Excimer Laser System - Ocular | WaveLight EX500 Excimer Laser System - Systemic |
|---|---|---|---|
| Visual acuity reducedEye disorders | 0/30 | 2/60 | 0/30 |
| Event | Pretreament | WaveLight EX500 Excimer Laser System - Ocular | WaveLight EX500 Excimer Laser System - Systemic |
|---|---|---|---|
| DiplopiaEye disorders | 0/30 | 7/60 | 0/30 |
| PhotophobiaEye disorders | 0/30 | 4/60 | 0/30 |
Safety Analysis Set: All eyes for which a refractive surgery was attempted with test device (regardless of success or failure).
| Age, Continuous(years) | WaveLight EX500 Excimer Laser System |
|---|---|
| Mean | 38.6 ± 10.42 |
| Sex: Female, Male(Participants) | WaveLight EX500 Excimer Laser System |
|---|---|
| Female | 19 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | WaveLight EX500 Excimer Laser System |
|---|---|
| White | 29 |
| Black or African American | 1 |
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Multi-Racial | 0 |
| Other | 0 |
| Race/Ethnicity, Customized(Participants) | WaveLight EX500 Excimer Laser System |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 26 |
| Not Reported | 0 |
| Unknown | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2021 to primary completion in May 2023, 24 months.
Results were first posted in May 2024, 1 year after primary completion.
Of 36 industry-sponsored interventional studies with no phase under Hyperopia, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's 24 months is above that.
Counting every sponsor, half of 54 studies reached it within 10 months; a quarter within 4 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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