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Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03647046
Recruitment Status : Completed
First Posted : August 27, 2018
Results First Posted : February 25, 2020
Last Update Posted : March 31, 2020
Ovitz Corporation
Boston Sight
Information provided by (Responsible Party):
Tara Vaz, University of Rochester

Brief Summary:
The goal of the study is to examine the effects of custom front-surface wavefront correction on visual performance, and on neutralization of higher order aberrations, in patients wearing a scleral lens device. The investigators will study patients with keratoconus, the most common type of corneal ectasia, who have already been fitted with the BostonSight BSS (Boston Sight Scleral) for improved visual function.

Condition or disease Intervention/treatment Phase
Keratoconus Device: Customized Scleral Lens Not Applicable

Detailed Description:

This study will be a single center, double-masked collection of data taking place at the Flaum Eye Institute. Informed consent will be obtained from all subjects after a thorough explanation of the nature and possible risks of the study. Flaum Eye Institute electronic health records of existing patients will first be screened by an optometrist or ophthalmologist to verify that they do not fall under the exclusion criteria. Some study communication regarding scheduling will be done over the phone or email. The screening will be similar to a standard eye exam (without eye dilation) and will include a slit lamp examination as well as visual acuity and basic vision evaluation.

The study eye will be chosen based on inclusion criteria; if both eyes qualify, the eye with worse best corrected acuity will be chosen. A new lens will be manufactured for the subject after the screening visit and will be given to the subject during the following study visit. This is done to ensure fully neutralized spherical refractive effort and positional stability. If screening evaluation reveals that the current lens does not fully neutralize spherical refractive error or that the current lens is not positionally stable, a baseline lens will be manufactured that corrects this. The subject will be allowed to keep the old lens if he or she so chooses.

At the second visit, the patient's vision and fit will be evaluated with the optimized baseline BSS lens. Visual acuity and device fit will be evaluated and recorded. If the BSS device fit is still not optimized, then a new device will be made , and the second visit evaluation will be rescheduled. Once the baseline lens design is determined to be satisfactory, the patient will have their wavefront aberration measured with a wavefront sensor. Investigators will dilate the pupil pharmacologically with phenylephrine (2.5%) and tropicamide (1%) and take wavefront measurements of the optical aberrations of the subject's eye wearing the baseline lens using a portable, non-invasive wavefront analyzer designed to measure highly aberrated eyes (Ovitz, P10/EyeProfiler). The investigators will then design and manufacture a study lens that is identical in design to the baseline BostonSight BSS lens except for a custom front surface designed to neutralize the optical aberrations measured with the wavefront analyzer. This HOA-optimized lens will be created prior to the third visit.

At the third visit the patient's vision and fit will be evaluated with the new HOA-optimized lens. A designated study team member will measure visual acuity and over-refraction of the patient. If an adjustment is needed for the lens, then a new device will be made, and the third visit evaluation will be rescheduled.

Once well-fitting baseline and HOA-optimized test lenses are established, both lenses will be remade and presented to the evaluator designated study team member in charge of evaluation and subject together in a masked fashion. During a fourth visit, the patient's vision will be extensively evaluated using standard non-invasive optometric measurements with each of the two lenses. First the patient will undergo a basic evaluation with each lens to ensure that the fit is correct. The patient will then undergo basic visual acuity; high and low contrast visual acuity, contrast sensitivity, and subjective vision scoring with each lens. The subject's wavefront aberration will also be measured again with each lens.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Customized Scleral Lens
A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.
Device: Customized Scleral Lens
A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens.

Primary Outcome Measures :
  1. Number of Participants With Normal Vision [ Time Frame: 30 minutes ]
    Vision will be tested using the Basic Snellen Visual Acuity test and normal vision will be defined as 20/20.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

A person will be included in the study if he/she:

  • Is 18 years or older and has full legal capacity to volunteer.
  • Has been diagnosed with Keratoconus;
  • Has no other active ocular disease;
  • Is currently wearing the BostonSight BSS in at least one eye ;
  • Has non-spherical BostonSight BSS haptic design in the study eye;
  • Has 20/400 or better best corrected visual acuity with pinhole 20/60 or better in the study eye;
  • Is not pregnant or nursing;
  • Has voluntarily agreed to participate in the study by signing the statement of informed consent;

A person will be excluded from the study if he/she:

  • Is under the age of 18;
  • Has best corrected visual acuity outside 20/400;
  • Pregnant or nursing at the time of enrollment in the study;

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 identifier (NCT number): NCT03647046

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United States, New York
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Ovitz Corporation
Boston Sight
  Study Documents (Full-Text)

Documents provided by Tara Vaz, University of Rochester:
Informed Consent Form  [PDF] August 27, 2019

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Responsible Party: Tara Vaz, Assistant Professor, University of Rochester Identifier: NCT03647046    
Other Study ID Numbers: 72749
First Posted: August 27, 2018    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: March 31, 2020
Last Verified: December 2019

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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 Tara Vaz, University of Rochester:
Keratoconus, scleral lens
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases