Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses

NCT02643095 | Completed Results

• 1 other identifier: 2015W0197
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.

Conditions

Scleral Lens Wearers

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses

  Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses

  1 month after lens is dispensed

Study Arms (1)

Lens fitting/evaluation

EXPERIMENTAL

This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.

Device: scleral contact lens

Interventions

scleral contact lens DEVICE

Scleral contact lens

Lens fitting/evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
• Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
• The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
• Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
• Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).

You may not qualify if:

• Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
• Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
• Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
• Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
• Subjects who are participating in any other clinical trial (FDA or other)

Sponsors & Collaborators

• Jennifer Fogt: lead

Results Point of Contact

• Title: Jennifer Fogt
• Organization: The Ohio State University College of Optometry

Fogt.78@osu.edu

614-292-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: December 30, 2015
• Study Start: January 26, 2016
• Primary Completion: August 8, 2016
• Study Completion: August 31, 2016
• Last Updated: December 6, 2023
• Results First Posted: September 13, 2018

Record last verified: 2023-11