HyperopiaNCT04616144
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
A study testing Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser in people with Hyperopia and High Astigmatism, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Hyperopia, High Astigmatism
- What is being tested?
- Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteKosovo
- Study dates
- 1 May 2019to 1 May 2027
- Phase
- Interventional
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with high spherical hyperopia over + 4.5 D
- astigmatism over + 3 cyl.
- corneal thickness minimum 450 µm and maximum 550 µm.
Who cannot join
- corneal thickness over 550 µm
- history of glaucoma
- retinal detachment
- cataract
- history of ocular inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Hyperopia, High Astigmatism
- Being tested
- Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond LaserDevice
Fresh Corneal Lenticule Implantation using ReLex-Smile
| Study group | Role | What they receive |
|---|---|---|
| FRESH CORNEAL LENTICULE IMPLANTATION | Other | 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. Receives: Device: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of visual acuity, accommodation process
Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)
Measured: 12 months
Secondary outcomes (1)
Decrease of high hyperopic astigmatism
In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 May 2019
- Primary completion1 May 2020
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Miopic Group Hyperopic Group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Hospital Pristina Kosovo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616144
- Sponsor's protocol ID
- EHospitalP
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided