Clinical trial NCT05888337: Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism
Official title: Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myopia
Astigmatism
Lead sponsor: Bismarck Lasik
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-06-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group
timeFrame: 3 months postoperatively
Other outcomes:
measure: Percentage of eyes with monocular UDVA of logMAR 0.00 (20/20) in each group
timeFrame: 3 months postoperatively
measure: Mean/SD of residual refractive error and centroid of manifest refraction (dioptric magnitude of residual astigmatism and residual SE)
timeFrame: 3 months postoperatively
measure: Percentage of eyes with postoperative UDVA equal to or better than their preoperative CDVA
timeFrame: 3 months postoperatively
measure: Percentage of eyes that gained 1 or more lines postoperative CDVA and preoperative CDVA
timeFrame: 3 months postoperatively
measure: Percentage of subjects that report overall visual preference of the Phorcides planned eye vs manifest refraction planned eye
timeFrame: 3 months postoperatively
measure: Quantitative rating of overall satisfaction of vision in each eye
timeFrame: 3 months postoperatively
Locations:
city: Bismarck
country: United States
facility: Bismarck Lasik
state: North Dakota
Study officials:
affiliation: Bismarck Lasik
name: Stephen A Wexler, MD
role: PRINCIPAL_INVESTIGATOR
References: