Neurolens and Contact Lens Discomfort

Contact Lens Discomfort Clinical Trial

Official title:

Neurolens and Contact Lens Discomfort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05801991
• Other study ID #: SCCOCLNeurolens
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Southern California College of Optometry at Marshall B. Ketchum University
• Contact: Erin Rueff, OD, PhD
• Phone: 714-463-7586
• Email: erueff[@]ketchum.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine how neurolens® influences contact lens discomfort in uncomfortable myopic soft contact lenses wearers. We hypothesize that uncomfortable soft contact lens wearers are experiencing some level of discomfort associated with increased vergence demand when looking at near targets and will experience discomfort relief when wearing neurolens® over their habitual soft contact lenses. Uncomfortable, myopic soft contact lens wearers will be recruited. Each participant will be masked and randomly assigned a placebo pair of spectacles or a neurolens® spectacle pair for approximately one month. A prospective, randomized clinical trial will be performed. Participants and investigators will be masked to the treatment.

Description:

Discomfort is the primary reason for contact lens dissatisfaction and discontinuation. Symptoms of contact lens discomfort are often attributed to dryness; however, severity of dry eye and discomfort symptoms is not correlated with clinical dry eye severity. When clinical signs of contact lens discomfort and dryness misalign with symptom severity, the possibility of an under-recognized etiology must be considered . Symptoms associated with contact lens discomfort are similar to symptoms reported with binocular vision disorders and accommodative and vergence strain. Eyestrain, fatigue, and increased/more frequent end-of-day symptoms are noted by patients in both groups of conditions. It has been reported that uncomfortable contact lens wearers have an unusually high prevalence of binocular vision disorders and clinical signs. Basic optical calculations show that myopes must converge and accommodate more when corrected with contact lenses versus spectacles, so it is reasonable to hypothesize that a myopic contact lens wearer may experience eyestrain and discomfort associated with vergence fatigue while wearing contact lenses, but not while wearing single vision spectacles. neurolens® is a type of spectacle lens that uses contoured prism to alleviate vergence demands and fatigue at near and, therefore, encourages comfortable vision. This spectacle design uses the neurolens® Measurement Device (nMD) to measure eye alignment and determine the spectacle lenses that are uniquely designed for each wearer. Acknowledging that some amount of contact lens discomfort may be caused by vergence fatigue, it is possible that uncomfortable contact lens wearers who wear neurolens® over their contact lenses will achieve discomfort relief. The objective of this study is to determine how neurolens® influences contact lens discomfort in uncomfortable myopic soft contact lenses wearers. We hypothesize that uncomfortable soft contact lens wearers are experiencing some level of discomfort associated with increased vergence demand when looking at near targets and will experience discomfort relief when wearing neurolens® over their habitual soft contact lenses. Uncomfortable, myopic soft contact lens wearers will be recruited. Each participant will be masked and randomly assigned a placebo pair of spectacles or a neurolens® spectacle pair for approximately one month. A prospective, randomized clinical trial will be performed. Participants and investigators will be masked to the treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Uncomfortable soft contact lens wearers (CLDEQ-8 = 17 points) Adult, pre-presbyopic age range (18 - 35 years) Visual acuity of 20/25 or better in each eye with habitual contact lenses

Soft, spherical, single vision soft contact lens wearer:

• Habitual contact lens sphere power -0.75 D or more myopic
• Habitual contact lens are spherical design
• Habitual soft contact lenses are single vision design
• Valid contact lens prescription at the date of the baseline No significant subjective over-refraction in either eye with habitual soft contact lenses
• Sphere: = 0.50 D myopia, = 0.50 D hyperopia
• Cylinder: = 0.75 D No history of ocular surgery No history of ocular disease, amblyopia, strabismus, or vision therapy No history of neurolens or prism spectacle correction No history of significant vertical phoria or vertical phoria correction No current ocular medication use No significant signs of dry eye in any eye: *= Grade 1 ocular surface staining
• Schirmer score = 7 mm
• Tear break-up time = 7 seconds

Appropriate fit and surface of habitual soft contact lenses:

• Sufficient movement, centration, and coverage
• No significant lens deposits
• No signs of corneal or conjunctival contact-lens related complications Valid measurement on the neurolens® Measurement Device (nMD2)
• A numerical neurolens value
• Acceptable Measurement Quality Index (MQI)
• No low MQI (<0.8) or convergence excess

Related Conditions & MeSH terms

• Contact Lens Discomfort

Intervention

Device:
• Neurolens
neurolens® is a type of spectacle lens that uses contoured prism to alleviate vergence demands and fatigue at near and, therefore, encourages comfortable vision.8 This spectacle design uses the neurolens® Measurement Device (nMD) to measure eye alignment and determine the spectacle lenses that are uniquely designed for each wearer.
• Placebo spectacle lens
Plano (no power) spectacle lenses will be assigned to the placebo group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southern California College of Optometry at Marshall B. Ketchum University	Neurolens Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in contact lens discomfort	Change in contact lens discomfort measured by the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)	30-35 days
Secondary	Change in convergence insufficiency symptoms	Change in convergence insufficiency symptoms measured by the Convergence Insufficiency Symptom Survey (CISS)	30-35 days
Secondary	Change in headache symptoms	Change in headache symptoms measured by the Headache Impact Test (HIT-6)	30-35 days
Secondary	Change in dry eye symptoms	Change in dry eye symptoms measured by the Standard Patient Evaluation of Eye Dryness (SPEED) survey	30-35 days