5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia

NCT07133737 | Enrolling By Invitation

• 1 other identifier: PHOBOS-5FU
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

The planned study will investigate and evaluate refractive stability, predictability, and safety in patients who underwent SMILE® pro surgery for hyperopia with or without astigmatism at least five years ago. This study aims to gain long-term insights into the predictability, safety, stability and side effects of the SMILE® pro procedure. It will evaluate the refractive outcome so the findings can optimize treatment nomograms and selection criteria while providing evidence of the long-term stability and predictability of the procedure. Approximately 100 patients in the Czech Republic and Germany will participate in this study. The study was reviewed and approved by an independent research ethics committee.The study will consist of a single visit, where standard, non-invasive and painless examinations will be performed. The course of this visit will correspond to the patient's last visit five years ago as part of the clinical trial

Conditions

Hyperopia

Keywords

relex; smile; eye surgery; hyperopia

Outcome Measures

Primary Outcomes (7)

• Loss of more than 2 lines of CDVA

  Less than 5.0% of eyes loose more than 2 lines of CDVA at 5 years follow-up compared to the baseline visit.

  Baseline, 12 months, 5 years

• Manifest refractive astigmatism greater than 2.0 D

  Induced manifest refractive astigmatism greater than 2.0 D should occur in less than 5% of subjects at 5 years follow-up.

  5 years

• MRSE stability within ±1.0 D

  At least 95% of eyes should be stable with a change in Manifest Refractive Spherical Equivalent within ±1D between 12 months and 5 years follow-up visits.

  12 months, 5 years

• CDVA worse than 20/40

  Less than 1.0% of eyes have a post-operative CDVA worse than 20/40 at 5 years follow-up.

  5 years

• UDVA better than 20/40

  At least 85% of eyes intended for emmetropia achieve an UDVA of 20/40 or better at 5 years follow-up.

  5 years

• MRSE target within ±0.5 D

  Post-operative SE relative to the intended target should be within ±0.50D in ≥50% of eyes.

  5 years

• MRSE target within ±1.0 D

  Post-operative SE relative to the intended target should be within ±1.00 D ≥75% of eyes.

  5 years

Secondary Outcomes (14)

• Change in CDVA

  Baseline, 12 months, 5 years

• Distribution of CDVA

  Baseline, 12 months, 5 years

• Distribution of UDVA

  Baseline, 12 months, 5 years

• Distribution of UNVA

  Baseline, 12 months, 5 years

• Distribution of MRSE

  Baseline, 12 months, 5 years

Study Arms (1)

post hyperopia correction

Patients who underwent hyperopia correction surgery using Femtosecond laser system VisuMax with treatment option ReLEx SMILE at least 5 years ago and were part of the original clinical investigation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population are patients who suffered from hyperopia and hyperopia with astigmatism (including presbyopic patients who might have a myopic target) and underwent the original PHOBOS clinical study are medically suitable to undertake the current clinical study investigation.

You may qualify if:

• Patients who underwent the SMILE hyperopic procedure as part of the study referenced PHOBOS.
• Patients should be able to understand the patient information and willing to sign an informed consent.
• Patients should be willing to comply with all examinations during the visit.

You may not qualify if:

• Patients with severe ocular or generic disorders that would prevent them from completed the visit.
• Patients not being able to understand and give informed consent.
• Patients who did not underwent the SMILE hyperopic procedure as part of the study referenced PHOBOS.

Sponsors & Collaborators

• Gemini Eye Clinic: lead

Study Sites (2)

Gemini Eye Clinic

Zlín, 76001, Czechia

Location

Universitätsklinikum Marburg - Klinik für Augenheilkunde

Marburg, 35043, Germany

Location

Related Publications (1)

• Waring GO 3rd, Reinstein DZ, Dupps WJ Jr, Kohnen T, Mamalis N, Rosen ES, Koch DD, Obstbaum SA, Stulting RD. Standardized graphs and terms for refractive surgery results. J Refract Surg. 2011 Jan;27(1):7-9. doi: 10.3928/1081597X-20101116-01. No abstract available.

  PMID: 21229953 BACKGROUND

Related Links

• the protocol of the original study - ClinicalTrials.gov ID: NCT03431571

MeSH Terms

Conditions

Hyperopia; Smiling

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Facial Expression; Nonverbal Communication; Communication; Behavior

Study Officials

• Pavel Stodulka, Dr. Ph.D, FEBOS-CR

  Gemini Eye Clinic

  PRINCIPAL INVESTIGATOR

• Anke Messerschmidt-Roth, Dr. rer. medic.

  Klinik für Augenheilkunde Marburg

  PRINCIPAL INVESTIGATOR

• Walter Sekundo, Prof. Dr. med.

  Klinik für Augenheilkunde Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 21, 2025
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

DE (1); CZ (1)