An observational study in Hyperopia, sponsored by Gemini Eye Clinic. Enrolling by invitation at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Gemini Eye Clinic · Observational
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
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's planned enrollment of 100 is below the median of 196 across 26 observational studies indexed under Hyperopia.
Browse Hyperopia studies →Gemini Eye Clinic is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Change in CDVA
Change in CDVA as a loss-of-line distribution at each time point (safety diagram)
Time frame: Baseline, 12 months, 5 years
Distribution of CDVA
Cumulative distribution of CDVA at each time point including safety index
Time frame: Baseline, 12 months, 5 years
Distribution of UDVA
Cumulative UDVA distribution at each time point compared to pre-operative CDVA
Time frame: Baseline, 12 months, 5 years
Distribution of UNVA
Cumulative UNVA distribution at each time point.
Time frame: Baseline, 12 months, 5 years
Distribution of MRSE
Spherical equivalent refractive accuracy
Time frame: Baseline, 12 months, 5 years
Change of MRSE
Stability of spherical equivalent refraction
Time frame: Baseline, 12 months, 5 years
Change of subjective refractive astigmatism
Stability of subjective refractive astigmatism
Time frame: Baseline, 12 months, 5 years
Adverse events incidence
Intraoperative and adverse events at each time point (numbers and percentages)
Time frame: Baseline, 12 months, 5 years
Quality of vision
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.
Time frame: 5 years
Contrast sensitivity changes
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).
Time frame: Baseline, 12 months, 5 years
Change in corneal keratometry
Comparision of mean corneal keratometry with an analysis diameter of 6 mm.
Time frame: Baseline, 12 months, 5 years
Change in higher order corneal abberations
Comparision of higher order corneal abberations with an analysis diameter of 6 mm.
Time frame: Baseline, 12 months, 5 years
Corneal epithelium thickness
Analysis of corneal epithelium thickness with an analysis of min-max difference in a diameter of 6 mm.
Time frame: 5 years
Pentacam Nucleaus Staging
Rate of Pentacam Nuclear Staging (PNS) providing a cataract grading score on an ordinal scale (from 0 to 5) where 0 is no cataract.
Time frame: 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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