NCT05684237

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

October 13, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

December 21, 2022

Last Update Submit

October 16, 2023

Conditions

MyopiaMyopic AstigmatismPresbyopia

Outcome Measures

Primary Outcomes (3)

  • Performance

    Percentage of eyes with ocular spherical aberration within the therapeutic range of 0.3 to 0.6 μm (Optical Society of America notation at 6 mm analysis diameter) at 3 months.

    3 Months

  • Performance

    Percentage of eyes with ocular spherical aberration within the therapeutic range of 0.3 to 0.6 μm (Optical Society of America notation at 6 mm analysis diameter) at 12 months.

    12 Months

  • Safety Outcome

    Percentage of eyes with loss of 2 lines (10 letters) or more of Corrected Distance Visual Acuity (CDVA) at 3 months postoperative compared to the baseline visit

    3 Months

Study Arms (1)

HiSMILE treatment option

OTHER

HiSMILE treatment option

Procedure: HiSMILE treatment option

Interventions

HiSMILE treatment optionPROCEDURE

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.

HiSMILE treatment option

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of myopia up to -10.00 D with or without astigmatism up to 5.00 D and a maximum spherical equivalent of -12.50 D (SMILE CE approved range)
  • Age of 40 years or older
  • Presence of presbyopia
  • Patients able to receive a refractive correction in both eyes and in addition a compensation of presbyopia, in which one eye should be targeted for far vision and one eye should be targeted for near vision
  • Pre-operative CDVA of 20/25 or better in each eye as well as a Distance Corrected Near Visual Acuity (DCNVA) of 20/25 (J2) or worse
  • Target refraction of the near eye between -0.50 D to -1.75 D
  • Acceptance of anisometropia (no visual discomfort or disturbances during the Acceptance Test before surgery, eye intended for near vision determined during this test)
  • Compliance with follow-up visits and examinations

You may not qualify if:

  • Presence of at least one of the contraindications stated in the User Manual of the VisuMax option SMILE or in the Surgical Information Package provided to the patient by the London Vision Clinic before surgery
  • Hyperopic refraction
  • Mixed astigmatism refraction
  • Emmetropic eyes, defined as spherical equivalent refraction \<-0.88 D, maximum hyperopia ≤+1.00 D and cylinder \<1.25 D
  • Patients presenting any kind of amblyopia
  • Previous intraocular or corneal surgery
  • Participation in other ophthalmologic or pharmaceutical studies
  • Women during pregnancy and/or lactation
  • Patients whose freedom is impaired by administrative or legal order
  • Persons incapable of giving consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Vision Clinic

London, W1G 7LA, United Kingdom

Location

MeSH Terms

Conditions

MyopiaAstigmatismPresbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Dan Reinstein

    London Vision Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 13, 2023

Study Start

October 13, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)