HyperopiaPHOBOS-5FUNCT07133737
5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia
An observational study of Hyperopia, run by Gemini Eye Clinic at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperopia
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
Universitätsklinikum Marburg - Klinik für Augenheilkunde
Marburg, 35043
About this study
Official 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
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
- Medical subject headings
- Hyperopia, Smiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Secondary outcomes (14)
Change in CDVA
Change in CDVA as a loss-of-line distribution at each time point (safety diagram)
Measured: Baseline, 12 months, 5 years
Distribution of CDVA
Cumulative distribution of CDVA at each time point including safety index
Measured: Baseline, 12 months, 5 years
Distribution of UDVA
Cumulative UDVA distribution at each time point compared to pre-operative CDVA
Measured: Baseline, 12 months, 5 years
Distribution of UNVA
Cumulative UNVA distribution at each time point.
Measured: Baseline, 12 months, 5 years
Distribution of MRSE
Spherical equivalent refractive accuracy
Measured: Baseline, 12 months, 5 years
Change of MRSE
Stability of spherical equivalent refraction
Measured: Baseline, 12 months, 5 years
Change of subjective refractive astigmatism
Stability of subjective refractive astigmatism
Measured: Baseline, 12 months, 5 years
Adverse events incidence
Intraoperative and adverse events at each time point (numbers and percentages)
Measured: 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.
Measured: 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).
Measured: Baseline, 12 months, 5 years
Change in corneal keratometry
Comparision of mean corneal keratometry with an analysis diameter of 6 mm.
Measured: Baseline, 12 months, 5 years
Change in higher order corneal abberations
Comparision of higher order corneal abberations with an analysis diameter of 6 mm.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Pavel Stodulka, Gemini Eye Clinic
- Investigators
- Pavel Stodulka, Dr. Ph.D, FEBOS-CR, Principal investigator, Gemini Eye ClinicAnke Messerschmidt-Roth, Dr. rer. medic., Principal investigator, Klinik für Augenheilkunde MarburgWalter Sekundo, Prof. Dr. med., Principal investigator, Klinik für Augenheilkunde Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133737
- Sponsor's protocol ID
- PHOBOS-5FU
- Acronym
- PHOBOS-5FU
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21229953