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Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism (WFG Sclerals)

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ClinicalTrials.gov Identifier: NCT04698590
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Cornea and Laser Eye Institute

Brief Summary:
Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.

Condition or disease Intervention/treatment Phase
Keratoconus Irregular Astigmatism Corneal Ectasia Aberration, Corneal Wavefront Wavefront Aberration, Corneal Pellucid Marginal Corneal Degeneration Keratoglobus Device: Wavefront Guided Scleral Lenses Device: Traditional Scleral Lenses Not Applicable

Detailed Description:
The purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. The derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. These lenses are custom made based on the individual measurements from an eye.The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: WFG Scleral Lenses
Scleral lenses with customized wavefront guided optics
Device: Wavefront Guided Scleral Lenses
Custom wavefront guided, higher order aberration correcting scleral lenses
Other Name: ARES Scleral Lenses

Placebo Comparator: Traditional Scleral Lenses
Scleral lenses with traditional optics
Device: Traditional Scleral Lenses
Traditional scleral lenses
Other Name: CS Scleral Lenses




Primary Outcome Measures :
  1. Higher order aberration [ Time Frame: 4 weeks ]
    Total higher order aberrations with traditional scleral lenses will be compared with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in total higher order aberrations with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated.


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 4 weeks ]
    Visual acuity with traditional scleral lenses will be compared to visual acuity with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in visual acuity from dispense to 4 week follow up, will be evaluated for signs of neural adaptation.

  2. Contrast Sensitivity [ Time Frame: 4 weeks ]
    Contrast sensitivity with traditional scleral lenses will be compared to contrast sensitivity with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in contrast sensitivity with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated for signs of neural adaptation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-A diagnosis of keratoconus or irregular astigmatism

Exclusion Criteria:

  • Patients with other visually significant ocular pathology.
  • Inability to apply or remove a scleral lens.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698590


Contacts
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Contact: BethAnn Furlong-Hibbert, BA 2018830505 bfurlong-hibbert@vision-institute.com
Contact: Stacey Lazar, BS 2018830505 slazar@vision-institute.com

Locations
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United States, New Jersey
Cornea and Laser Eye Institue - Hersh Vision Group Recruiting
Teaneck, New Jersey, United States, 07666
Contact: BethAnn Furlong-Hibbert, BA    201-883-0505    bfurlong-hibbert@vision-institute.com   
Contact: Stacey Lazar, BS    201-883-0505    slazar@vision-institute.com   
Principal Investigator: John D Gelles, OD         
Sponsors and Collaborators
Cornea and Laser Eye Institute
Investigators
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Principal Investigator: John D Gelles, OD The Cornea and Laser Eye Institute
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Responsible Party: Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier: NCT04698590    
Other Study ID Numbers: CLEI WFG Scleral Lens
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cornea and Laser Eye Institute:
Keratoconus
Scleral lenses
Scleral lens
Wavefront guided scleral lenses
Higher order aberrations
HOA scleral lenses
Sclerals
Higher order aberration correction
Custom scleral lenses
Wavefront guided
Irregular Astigmatism
WFG scleral lenses
Additional relevant MeSH terms:
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Keratoconus
Astigmatism
Corneal Wavefront Aberration
Corneal Diseases
Eye Diseases
Refractive Errors