Click2Print Artificial Eyes

NCT05093348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-11-30

No results posted yet for this study

Summary

To undertake a randomised crossover trial in human subjects the Click2Print ocular prosthesis versus an analogue ocular prosthesis demonstrating non-inferiority in the assessment of ocular prosthesis motility, cosmesis, fit and function, comfort, mucous discharge and benefits of use in daily life in 40 data subjects (Crossover Trial).

Conditions

  • Enucleated; Eye
  • Evisceration; Traumatic, Eye

Interventions

DEVICE

Click2Print artificial eye

Digitally designed and manufactured ocular prosthesis

DEVICE

Hand-made artificial eye

Hand-made artificial eye

Sponsors & Collaborators

  • Moorfields Eye Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Mandeep Sagoo · Moorfields Eye Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2023-07-16
Completion
2023-07-16

Countries

  • United Kingdom

Study Locations

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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 NCT05093348 on ClinicalTrials.gov