Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WaveLight EX500 excimer laser system | Experimental | Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WaveLight EX500 excimer laser system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to Month 12 postoperative |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durrie Vision | Overland Park | Kansas | 66210 | United States | ||
| Moyes Eye Center |
Not provided
Not provided
Not provided
Not provided
Not provided
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 were recruited from 5 investigative sites located in 1 country (US).
| ID | Title | Description |
|---|---|---|
| FG000 | WaveLight EX500 Excimer Laser System | Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set: All eyes for which a refractive surgery was attempted with test device (regardless of success or failure).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | WaveLight EX500 Excimer Laser System | Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit. | Posted | Number | percentage of eyes | 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) | eyes | eyes |
|
Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year.
AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreament | AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Projects Director, Surgical | Alcon Research, LLC | 18884513937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2021 | Apr 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2023 | Apr 26, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| LASIK | Procedure | 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. |
|
| Kansas City |
| Missouri |
| 64154 |
| United States |
| Physicians Protocol | Greensboro | North Carolina | 27401 | United States |
| Vance Thompson Vision ND | West Fargo | North Dakota | 58078 | United States |
| Mann Eye Institute | Houston | Texas | 77004 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system |
|
|
|
| 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. | Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit. | Posted | Number | percentage of eyes | 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) | eyes | eyes |
|
|
|
|
| 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. | Safety Analysis Set: all eyes for which refractive surgery was attempted with the test device (regardless of success or failure). | Posted | Number | percentage of eyes | Up to Month 12 postoperative | eyes | eyes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | WaveLight EX500 Excimer Laser System - Ocular | AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include ocular events in the study eye. | 0 | 60 | 2 | 60 | 10 | 60 |
| EG002 | WaveLight EX500 Excimer Laser System - Systemic | AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include overall systemic events. | 0 | 30 | 0 | 30 | 0 | 30 |
| Photophobia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to study.
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| Title | Measurements |
|---|---|
|
| Ocular hyperaemia |
|