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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05888337
• Other study ID #: SW-23-01
• Status: Terminated
• Start date: June 20, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: Bismarck Lasik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• Contoura LASIK with Phorcides planning strategy
Bilateral treatment with topography guided LASIK
• Contoura LASIK with manifest refraction planning strategy
Bilateral treatment with topography guided LASIK

Locations

Country	Name	City	State
United States	Bismarck Lasik	Bismarck	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Bismarck Lasik	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of eyes with monocular UDVA of logMAR 0.00 (20/20) in each group		3 months postoperatively
Other	Mean/SD of residual refractive error and centroid of manifest refraction (dioptric magnitude of residual astigmatism and residual SE)		3 months postoperatively
Other	Percentage of eyes with postoperative UDVA equal to or better than their preoperative CDVA		3 months postoperatively
Other	Percentage of eyes that gained 1 or more lines postoperative CDVA and preoperative CDVA		3 months postoperatively
Other	Percentage of subjects that report overall visual preference of the Phorcides planned eye vs manifest refraction planned eye		3 months postoperatively
Other	Quantitative rating of overall satisfaction of vision in each eye	Satisfaction will be measured using a questionnaire. Subjects will rate satisfaction with vision in each eye using the scale: Completely Dissatisfied; Very Dissatisfied; Somewhat Dissatisfied; Somewhat Satisfied; Very Satisfied; Completely Satisfied	3 months postoperatively
Primary	Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group		3 months postoperatively
Secondary	Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group		3 months postoperatively