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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus

NCT07559188 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-30

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the effectiveness of the NOA lens, a custom-made scleral contact lens developed by Azalea Vision BV, in improving visual quality for individuals with keratoconus and presbyopia.

This clinical study investigates a new lens design featuring a specific central aperture (opening) intended to enhance image quality by increasing depth of focus and reducing optical aberrations. The NOA lens serves as a functional prototype for future "smart lens" technology, specifically the ALMA Smart Lens. The study aims to determine if this specialized lens provides a solution for patients whose visual needs are not fully met by conventional glasses or contact lenses.

The investigation will compare a standard refractive scleral lens (Type 1) against the aperture-integrated lens (Type 2) to validate the "pinhole effect" in improving vision and reducing higher-order aberrations.

Conditions

  • Keratoconus
  • Presbyopia
  • Scleral Contact Lenses
  • Pinhole

Interventions

DEVICE

NOA lens type 1

Provides standard refractive correction. It is a clear (un-printed) lens used only to design the type 2 lens by assessing on-eye centration and stability. It also acts as the reference standard for baseline assessments in the NOA study

DEVICE

NOA lens type 2

Incorporates an integrated optical aperture (pinhole) created by an opaque dye, in addition to standard refractive correction. This opaque layer is printed on an internal surface and sealed within the lens cavity. The inclusion of this optical aperture is intended to enhance depth of focus (the "pinhole effect") and reduce the impact of optical aberrations

Sponsors & Collaborators

  • Azalea Vision

    lead INDUSTRY

Principal Investigators

  • Koppen · University Hospital, Antwerp

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Belgium
  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07559188 on ClinicalTrials.gov