Active, not recruitingNCT04616144Updated Jul 29, 2026

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

An interventional study of Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser in Hyperopia and High Astigmatism, sponsored by Eye Hospital Pristina Kosovo. Active, not recruiting at 1 site in Kosovo. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 5 months after the study started (first participant enrolled May 2019, registered Oct 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 55
Allocation: Not applicable
Ages: 20 Years to 50 Years
Sex: All

Study summary

The refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method. Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation (loss of accommodation, endophthalmitis). Its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. We believe this study will be the future of refractive surgery for treating high hyperopia.

Read the detailed description

This study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess (increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize (decrease) high astigmatism by reducing K-values.

Conditions studied

Hyperopia
High Astigmatism

Browse trials for

Hyperopia 156

In context

Hyperopia

156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.

This study's planned enrollment of 55 is close to the median of 60 across 125 interventional studies indexed under Hyperopia.

Browse Hyperopia studies →

Lead sponsor

Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

patients with high spherical hyperopia over + 4.5 D
astigmatism over + 3 cyl.
corneal thickness minimum 450 µm and maximum 550 µm.

Exclusion criteria

Exclusion Criteria:

corneal thickness over 550 µm
history of glaucoma
retinal detachment
cataract
history of ocular inflammation.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 55 participants (estimated)

Study arms

Other
FRESH CORNEAL LENTICULE IMPLANTATION
The aim of this study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize(decrease) high astigmatism by reducing K values. Fresh corneal lenticule implantation as allogenic implant that we took from myopic patients (-5.0D) to implant in hyperopic patients (+4.0 D +3.0cyl) according to high K2 values. The stromal pocket diameter was 8 mm, 4mm super incision and 130-µm cap thickness.
Device: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser

Interventions

DeviceFresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
Fresh Corneal Lenticule Implantation using ReLex-Smile

What researchers measure

Primary outcomes

Increase of visual acuity, accommodation process
Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)
Time frame: 12 months

Secondary outcomes

Decrease of high hyperopic astigmatism
In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.
Time frame: 12 months

Study locations

1 site

Eye Hospital Pristina
Pristina, 10000, Kosovo
7 other open studies at this site →

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2019 to primary completion in May 2020, 12 months.

Of 54 interventional studies with no phase under Hyperopia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 24. This study's 12 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 26, 2020
First posted: Nov 4, 2020
StartActual: May 1, 2019
Primary completionActual: May 1, 2020
CompletionEst.: May 1, 2027
Last update: Jul 29, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04616144
Lead sponsor: Eye Hospital Pristina Kosovo
Responsible party: Dr. Faruk Semiz (Head of Ophthalmology Department, Eye Hospital Pristina Kosovo) — Principal investigator
First posted: Nov 4, 2020
Start date: May 1, 2019
Primary completion: May 1, 2020
Completion: May 1, 2027 (estimated)
Last update: Jul 29, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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