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Enrolling by Invitation

NCT Number: NCT07133737

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

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

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Key information

Conditions

Hyperopia Behavior Communication Eye Diseases Facial Expression Nonverbal Communication Refractive Errors Smiling

Sex eligibility

All sexes

Study type

Observational

Primary location

Gemini Eye Clinic, Zlín, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Loss of more than 2 lines of CDVA

    Time frame: Baseline, 12 months, 5 years

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

  2. Manifest refractive astigmatism greater than 2.0 D

    Time frame: 5 years

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

  3. MRSE stability within ±1.0 D

    Time frame: 12 months, 5 years

    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.

  4. CDVA worse than 20/40

    Time frame: 5 years

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

  5. UDVA better than 20/40

    Time frame: 5 years

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

  6. MRSE target within ±0.5 D

    Time frame: 5 years

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

  7. MRSE target within ±1.0 D

    Time frame: 5 years

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

Secondary outcomes

  1. Change in CDVA

    Time frame: Baseline, 12 months, 5 years

    Change in CDVA as a loss-of-line distribution at each time point (safety diagram)

  2. Distribution of CDVA

    Time frame: Baseline, 12 months, 5 years

    Cumulative distribution of CDVA at each time point including safety index

  3. Distribution of UDVA

    Time frame: Baseline, 12 months, 5 years

    Cumulative UDVA distribution at each time point compared to pre-operative CDVA

  4. Distribution of UNVA

    Time frame: Baseline, 12 months, 5 years

    Cumulative UNVA distribution at each time point.

  5. Distribution of MRSE

    Time frame: Baseline, 12 months, 5 years

    Spherical equivalent refractive accuracy

  6. Change of MRSE

    Time frame: Baseline, 12 months, 5 years

    Stability of spherical equivalent refraction

  7. Change of subjective refractive astigmatism

    Time frame: Baseline, 12 months, 5 years

    Stability of subjective refractive astigmatism

  8. Adverse events incidence

    Time frame: Baseline, 12 months, 5 years

    Intraoperative and adverse events at each time point (numbers and percentages)

  9. Quality of vision

    Time frame: 5 years

    Evaluation of patient satisfaction using patient questionnaire with focus on quality of vision. A Rasch-Analysis will be performed based on a questionnaire to evaluate the QoV (Quality of Vision) with a lower score indicating better vision and higher worse vision.

  10. Contrast sensitivity changes

    Time frame: Baseline, 12 months, 5 years

    Determination of contrast sensitivity measured by CSV 1000 (Vector Vision) (changes from the pre-operative to the post-operative state and its stability over time will be investigated).

  11. Change in corneal keratometry

    Time frame: Baseline, 12 months, 5 years

    Comparision of mean corneal keratometry with an analysis diameter of 6 mm.

  12. Change in higher order corneal abberations

    Time frame: Baseline, 12 months, 5 years

    Comparision of higher order corneal abberations with an analysis diameter of 6 mm.

  13. Corneal epithelium thickness

    Time frame: 5 years

    Analysis of corneal epithelium thickness with an analysis of min-max difference in a diameter of 6 mm.

  14. Pentacam Nucleaus Staging

    Time frame: 5 years

    Rate of Pentacam Nuclear Staging (PNS) providing a cataract grading score on an ordinal scale (from 0 to 5) where 0 is no cataract.

Sponsors and collaborators

Lead sponsor

Gemini Eye Clinic

Industry

Registry information

Official study title

Follow-up Study of at Least 5 Years After a SMILE® Pro Procedure for the Correction of Hyperopia Investigating Long-term Visual Outcomes and Potential Side Effects

Acronym: PHOBOS-5FU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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