NCT03431571

Brief Summary

The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
6 countries

8 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.5 years

First QC Date

January 26, 2018

Last Update Submit

February 21, 2020

Conditions

Hypermetropia

Keywords

ReLExSMILEHyperopiaVisuMaxSmall Incision Lenticule ExtractionLenticuleFarsightedness

Outcome Measures

Primary Outcomes (1)

  • Corrected Distance Visual Acuity (CDVA)

    CDVA in logMar

    12 months

Secondary Outcomes (5)

  • side effects

    12 months

  • contrast sensitivity

    12 months

  • patient satisfaction (Quality of Vision Questionnaire)

    12 months

  • manifest refractive astigmatism

    12 months

  • spherical equivalent (SE)

    12 months

Study Arms (1)

Single arm

OTHER

ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group

Procedure: ReLEx SMILE

Interventions

ReLEx SMILEPROCEDURE

the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal corneal topography;
  • Predicted post-operative keratometry ≤51 D;
  • Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
  • Patients should be able to understand the patient information and willing to sign an informed consent;
  • Patients should be willing to comply with all follow-up visits and the respective examinations;
  • Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
  • The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
  • A difference between cycloplegic and manifest refractions of ≤1.00 D spherical equivalent in the eye to be treated;

You may not qualify if:

  • Mixed astigmatism
  • Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Medical Center Shanghai

Shanghai, China

Location

Tianjin Eye Hospital, Heping District

Tianjin, China

Location

Gemini Eye Clinic

Zlín, Czechia

Location

University Medical Center CHRU Brest

Brest, France

Location

Medical Center Heliosklinikum

Erfurt, Germany

Location

University Medical Center Universitätsklinikum Gießen Marburg

Marburg, Germany

Location

Medical Center Nethradhama Superspeciality Eye Hospital

Bangalore, India

Location

London Vision Clinic

London, United Kingdom

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Walter Sekundo

    Uniklinikum Gießen Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 13, 2018

Study Start

July 5, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)CN(2)CZ(1)DE(2)IN(1)GB(1)