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Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism

NCT ID: NCT05888337

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-20

Study Completion Date

2023-12-05

Brief Summary

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The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.

Detailed Description

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This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.

Conditions

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Myopia Astigmatism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Contoura LASIK with Phorcides planning strategy

Contoura LASIK with Phorcides planning strategy

Intervention Type DEVICE

Bilateral treatment with topography guided LASIK

Contoura LASIK with manifest refraction planning strategy

Contoura LASIK with manifest refraction planning strategy

Intervention Type DEVICE

Bilateral treatment with topography guided LASIK

Interventions

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Contoura LASIK with Phorcides planning strategy

Bilateral treatment with topography guided LASIK

Intervention Type DEVICE

Contoura LASIK with manifest refraction planning strategy

Bilateral treatment with topography guided LASIK

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years old and above
* Preoperative total corneal Pachymetry 490um or above
* BCVA 20/20 or better
* Stable refractive error \<0.50D MRSE change in preceding year
* Good general and ocular health
* Preoperative exam completed within three months of surgery
* Soft contact lens wear discontinued 3 days prior to preoperative exam and the procedure
* Residual stromal bed greater than 270um
* Candidates who qualify for Contoura treatment OU (≤ -8.0 D SPH and ≤ -3.0 D CYL)
* Candidates who elect to target both eyes targeted for emmetropia
* ≤ -3.0 D Oblique astigmatism as defined as an axis between 30-60 degrees or between 120-150 degrees

Exclusion Criteria

* Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
* Pachymetry below 490
* Autoimmune or immunodeficiency diseases, Pregnant or nursing women
* Subjects with signs of inability to understand consent for study and procedure planned
* Subjects with history of previous ocular surgery

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sengi

INDUSTRY

Sponsor Role collaborator

Bismarck Lasik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen A Wexler, MD

Role: PRINCIPAL_INVESTIGATOR

Bismarck Lasik

Locations

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Bismarck Lasik

Bismarck, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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SW-23-01

Identifier Type: -

Identifier Source: org_study_id