An interventional study of ReLEx SMILE in Hypermetropia, sponsored by Carl Zeiss Meditec AG. Status unknown at 8 sites in 6 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Carl Zeiss Meditec AG · Not applicable, Interventional, and Treatment
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Among 11 studies in Hyperopia with a site in China — 5 open to participants now, 5 under way, none of them phase 3. Hyperopia · China.
Among the 11 studies in Hyperopia with a site in China, this one is the 2nd largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is one of 8 with no phase, and was the 4th registered.
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
Browse Hyperopia studies →5 of the 11 studies in Hyperopia with a site in China are open now. Recruiting first, the newest first:
Shanghai Eye Disease Prevention and Treatment Center · Sites in China
Ages 6–11 · Healthy volunteers
Shanghai Eye Disease Prevention and Treatment Center · Sites in China
Ages 6–11 · Healthy volunteers
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 6–10 · Healthy volunteers
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 6–12
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 6–12
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 8 Hyperopia studies recruiting now, 3 set no upper age limit and 5 stop at 75 or younger; 5 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 374 is above the median of 60 across 125 interventional studies indexed under Hyperopia.
Median enrollment 143 across the 10 interventional studies, 1,901 across the 1 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 11 have an industry lead sponsor. The 9 most frequent:
Carl Zeiss Meditec AG is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Carl Zeiss Meditec AG has 2 studies filed under Hyperopia — fewer than ten, so there is no comparison to draw.
5 of the studies in Hyperopia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07746804Shanghai Eye Disease Prevention and Treatment CenterSchool-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve | 2027-06 |
| NCT07746752Shanghai Eye Disease Prevention and Treatment CenterSchool-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve | 2027-06 |
| NCT07142928Zhongshan Ophthalmic Center, Sun Yat-sen UniversityEffect of Light-Blocking Lenses on Hyperopic Anisometropic Children | 2027-06-30 |
| NCT07142915Zhongshan Ophthalmic Center, Sun Yat-sen UniversityEffect of Light-Blocking Lenses on Pediatric Hyperopia | 2027-06-30 |
| NCT07401511Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineEfficacy of S.T.O.P®KIT in Retarding Axial Length Growth in Children With Low Hyperopia | 2027-07-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 11 studies in Hyperopia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.
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.
ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group
Procedure: ReLEx SMILE
the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea
Corrected Distance Visual Acuity (CDVA)
CDVA in logMar
Time frame: 12 months
side effects
distribution in percent
Time frame: 12 months
contrast sensitivity
contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar
Time frame: 12 months
patient satisfaction (Quality of Vision Questionnaire)
Mean +/- standard deviation
Time frame: 12 months
manifest refractive astigmatism
Astigmatism in diopters \[D\]
Time frame: 12 months
spherical equivalent (SE)
SE in diopters \[D\]
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2017 (actual). Primary completion is estimated for Dec 2020, 41 months after the start.
Of 36 industry-sponsored interventional studies with no phase under Hyperopia, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 41 months is above that.
Counting every sponsor, half of 54 studies reached it within 10 months; a quarter within 4 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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