Comparison of Contoura Vision Outcomes Programmed Using t... | NCT05888337

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficult to find recruit patients with oblique astigmatism

Expanded Access Info

Start Date

Jun 20, 2023Actual

Primary Completion Date

Dec 5, 2023Actual

Completion Date

Dec 5, 2023Actual

First Submitted Date

May 25, 2023

First Submission Date that Met QC Criteria

May 25, 2023

First Posted Date

Jun 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 13, 2023Actual

Name	Class
Sengi	INDUSTRY

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contoura LASIK with Phorcides planning strategy			Device: Contoura LASIK with Phorcides planning strategy
Contoura LASIK with manifest refraction planning strategy			Device: Contoura LASIK with manifest refraction planning strategy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Contoura LASIK with Phorcides planning strategy	Device	Bilateral treatment with topography guided LASIK	Contoura LASIK with Phorcides planning strategy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group		3 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group		3 months postoperatively

Other Outcomes

Measure	Description	Time Frame
Percentage of eyes with monocular UDVA of logMAR 0.00 (20/20) in each group		3 months postoperatively
Mean/SD of residual refractive error and centroid of manifest refraction (dioptric magnitude of residual astigmatism and residual SE)		3 months postoperatively

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

Sampling Method

Non-Probability Sample

ID	Term
D009216	Myopia
D001251	Astigmatism

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases