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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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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
Are there results?: Not yet: the study is under way

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.

Country

City, postcode or hospital

2 sites in 2 countries

Czechia1 site

Gemini Eye Clinic
Zlín, 76001

Other trials in Czechia

Germany1 site

Universitätsklinikum Marburg - Klinik für Augenheilkunde
Marburg, 35043

Other trials in Germany

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

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 groups in NCT07133737
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.

1 Jan 202531 Dec 2025

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)

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors

All Hyperopia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07133737
Acronym / sponsor ID: PHOBOS-5FU / PHOBOS-5FU
Conditions: Hyperopia
Keywords: relex, smile, eye surgery, hyperopia
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 100 participants (estimated)
Lead sponsor: Gemini Eye ClinicIndustry (pharma, biotech, devices)
Study start: 1 Jan 2025 (actual)
Primary completion: 1 Sep 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 21 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: 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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.
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.
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.
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.

14 secondary outcomes

Change in CDVA
Time frame: Baseline, 12 months, 5 years
Distribution of CDVA
Time frame: Baseline, 12 months, 5 years
Distribution of UDVA
Time frame: Baseline, 12 months, 5 years
Distribution of UNVA
Time frame: Baseline, 12 months, 5 years
Distribution of MRSE
Time frame: Baseline, 12 months, 5 years
Change of MRSE
Time frame: Baseline, 12 months, 5 years
Change of subjective refractive astigmatism
Time frame: Baseline, 12 months, 5 years
Adverse events incidence
Time frame: Baseline, 12 months, 5 years
Quality of vision
Time frame: 5 years
Contrast sensitivity changes
Time frame: Baseline, 12 months, 5 years
Change in corneal keratometry
Time frame: Baseline, 12 months, 5 years
Change in higher order corneal abberations
Time frame: Baseline, 12 months, 5 years
Corneal epithelium thickness
Time frame: 5 years
Pentacam Nucleaus Staging
Time frame: 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
Background: PubMed 21229953Waring 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.
the protocol of the original study - ClinicalTrials.gov ID: NCT03431571Link provided by the sponsor.

Related trials for Hyperopia

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Pavel Stodulka, Dr. Ph.D, FEBOS-CR principal investigator

Gemini Eye Clinic

Anke Messerschmidt-Roth, Dr. rer. medic. principal investigator

Klinik für Augenheilkunde Marburg

Walter Sekundo, Prof. Dr. med. principal investigator

Klinik für Augenheilkunde Marburg

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperopia, run by Gemini Eye Clinic at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loss of more than 2 lines of CDVA (time frame: Baseline, 12 months, 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07133737, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.