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Using the VisuMax Femtosecond Laser System to Perform SMILE Optimized for Presbyopia by Modulation of Postoperative Spherical Aberration

NCT05684237 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-10-18

No results posted yet for this study

Summary

The intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser.

Conditions

Interventions

PROCEDURE

HiSMILE treatment option

The non-CE labeled VisuMax treatment option HiSMILE is able to modify the lenticule shape in a way that should lead to a change in spherical aberration postoperatively.

Sponsors & Collaborators

  • London Vision Clinic

    lead OTHER

Principal Investigators

  • Dan Reinstein · London Vision Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • United Kingdom

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 NCT05684237 on ClinicalTrials.gov