Enhancing Scleral Lens Fit With Advanced Imaging

Condition(s) studied

Study summary

The goal of this experimental clinical trial is to enhance the predictability and precision of scleral lens fitting in patients with complex corneal conditions such as keratoconus, post-surgical irregularities, and severe dry eye syndrome. The main questions it aims to answer are:

Can detailed sagittal height measurements obtained from the Oculus Pentacam Corneal Scleral Profile (CSP) predict the necessary adjustments for optimal scleral lens fit? Will the use of these measurements reduce the number of trial-and-error adjustments needed to achieve an ideal fit, thereby reducing chair time and improving patient satisfaction?

Participants will:

Undergo detailed corneal and scleral tomography using the Oculus Pentacam with the CSP strategy.

Receive customized ICD 16.5 mm scleral lenses based on precise measurements of their ocular surface.

Participate in follow-up assessments to evaluate the fit of the lenses and provide feedback on comfort and visual outcomes.

This study focuses on a specific participant population of adults aged 18 and older who have not had success with other types of contact lenses. By leveraging advanced imaging technologies, the research aims to streamline the fitting process for scleral lenses, potentially setting new standards for treatment efficacy in specialty contact lens practices.

Eligibility

Primary outcome measure(s)

• Predictive Accuracy of Sagittal Height for Scleral Lens Fit — Throughout the study duration, from initial measurement to final lens fitting (approximately 6 months)
  This primary outcome measure evaluates the predictive accuracy of sagittal height measurements obtained using the Oculus Pentacam at 10 mm, limbus, and 15 mm in determining the necessary adjustments to achieve optimal scleral lens fit. The main goal is to establish how closely the sagittal heights at these specific points predict the required lens sagittal depth to achieve a targeted central vault of approximately 300 microns. This outcome will assess the effectiveness of using Pentacam CSP data to reduce the number of fitting sessions and adjustments, thereby increasing the efficiency of the scleral lens fitting process. The expected result is a validated predictive model correlating specific sagittal height measurements with precise lens fitting parameters, potentially setting new standards for custom scleral lens adaptations.

Trial sites (1)

Other trials for the same condition