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| Name | Class |
|---|---|
| Science in Vision | OTHER |
| Alcon Research | INDUSTRY |
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The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms.
The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phorcides | Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phorcides Analytical Engine | Device | Surgery planning using the Phorcides analytical engine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Refractive Cylinder | Residual refractive cylinder in diopters | 3 months postop |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity | Uncorrected visual acuity at distance (4-6m) | 3 months postop |
| Residual Refractive Sphere | Residual refractive spherical equivalent in diopters |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects presenting for myopic LASIK correction who are eligible for treatment with topography-guided ablation in both eyes.
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Stulting | Woolfson Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolfson Eye Institute | Atlanta | Georgia | 30328 | United States | ||
| North Suburban Eye Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32425495 | Background | Stulting RD, Durrie DS, Potvin RJ, Linn SH, Krueger RR, Lobanoff MC, Moshirfar M, Motwani MV, Lindquist TP, Stonecipher KG. Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods. Clin Ophthalmol. 2020 Apr 24;14:1091-1100. doi: 10.2147/OPTH.S244079. eCollection 2020. | |
| 32176160 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phorcides | Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2020 |
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| 3 months postop |
| Satisfaction and Vision | A questionnaire related to visual quality and satisfaction after surgery | 3 months postop |
| Coon Rapids |
| Minnesota |
| 55433 |
| United States |
| TLC Laser Eye Center | Chesterfield | Missouri | 63017 | United States |
| Laser Defined Vision | Greensboro | North Carolina | 27401 | United States |
| Mann Eye Institute and Laser Centers | Houston | Texas | 77002 | United States |
| Lobanoff M, Stonecipher K, Tooma T, Wexler S, Potvin R. Clinical outcomes after topography-guided LASIK: comparing results based on a new topography analysis algorithm with those based on manifest refraction. J Cataract Refract Surg. 2020 Jun;46(6):814-819. doi: 10.1097/j.jcrs.0000000000000176. |
| 35171146 | Derived | Stulting RD, Lobanoff M, Mann PM 2nd, Wexler S, Stonecipher K, Potvin R. Clinical and refractive outcomes after topography-guided refractive surgery planned using Phorcides surgery planning software. J Cataract Refract Surg. 2022 Sep 1;48(9):1010-1015. doi: 10.1097/j.jcrs.0000000000000910. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phorcides | Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine. |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only subjects competing the 3-month visit were included | Mean | Standard Deviation | years | Participants |
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| ||||||||||||||||||
| Sex: Female, Male | Only subjects completing the 3-month visit are included | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| MRSE | Mean | Standard Deviation | diopters | Eyes |
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| Refractive cylinder | Mean | Standard Deviation | diopters | Eyes |
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| Uncorrected distance VA | Mean | Standard Deviation | logMAR (log of min angle of resolution | Eyes |
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| |||||||||||||||||||
| Corrected distance VA | Mean | Standard Deviation | logMAR | Eyes |
|
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| 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 | Residual Refractive Cylinder | Residual refractive cylinder in diopters | Posted | Mean | Standard Deviation | diopters | 3 months postop | Eyes | Eyes |
|
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| Secondary | Uncorrected Distance Visual Acuity | Uncorrected visual acuity at distance (4-6m) | Posted | Mean | Standard Deviation | logMAR | 3 months postop | Eyes | Eyes |
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| |||||||||||||||||||||||||||
| Secondary | Residual Refractive Sphere | Residual refractive spherical equivalent in diopters | Posted | Mean | Standard Deviation | diopters | 3 months postop | Eyes | Eyes |
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| Secondary | Satisfaction and Vision | A questionnaire related to visual quality and satisfaction after surgery | Posted | Count of Participants | Participants | 3 months postop |
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3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phorcides | Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. Phorcides Analytical Engine: Surgery planning using the Phorcides analytical engine. | 0 | 70 | 0 | 70 | 1 | 70 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epithelial defect | Eye disorders | Systematic Assessment | Epithelial defect |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Doyle Stulting, MD, PhD | Woolfson Eye Institute | (770) 255-3330 | dstulting@icloud.com |
| Feb 9, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Denominators | Categories |
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| Double vision |
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| Trouble driving at night |
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| Trouble reading |
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| Dryness |
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| Foreign body sensation |
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| Fluctuation in vision |
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| Glare |
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| Halos |
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| Light sensitivity |
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| Pain |
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| Starbursts |
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