PseudophakiaNCT04712318
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
A study testing Relex Smile and Relex smile with fresh corneal lenticule implantation in people with Pseudophakia and Myopia, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial summary
Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Pseudophakia, Myopia, Hyperopia
- What is being tested?
- Relex Smile and Relex smile with fresh corneal lenticule implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Jun 2016to 1 Jun 2027
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- residual hypermetropic, myopic refraction on pseudophakic patients
- low visual acuity
Who cannot join
- active anterior segment pathologic features,
- previous corneal or anterior segment surgery,
- glaucoma,
- retinal detachment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Succesful Treatment of Residual Refraction Errors (Myopic and Hyperopic) 6 Months After Trifocal IOL Implantation With Relex-Smile
Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.
Read the detailed description
Residual refractive errors(myopia 50% and hyperopia 30%) are the main problems at patients after IOL Implantation.
The residual refraction (myopic and hyperopic) after IOL Implantation is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition.
Two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (RLE) and excimer laser ablation (LASIK or PRK).
Laser procedures: Photorefractive keratectomy (PRK); Laser assisted in situ keratomileusis (LASIK); Risks of LASIK include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of BCVA, infectious keratitis, symptoms, and diffuse lamellar keratitis.
Refractive lens exchange (RLE); The risks of RLE are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment.
The aim of our study is to investigate the effect of Relex-Smile to treat the residual refraction errors (myopia and hypermetropia) 6 months after IOL Implantation.
Before SMILE, Yag-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE ,there will be a diopter change. In pseudophakic patients with hyperopic astigmatism and residual refraction ,corneal topography-guided intrastromal fresh lenticular implantation should be performed and the lenticule was placed according to the low K value.
At myopic residual refraction(-0.75D till -5.50D) after IOL Implantation The method used at the EYE Hospital Pristina by ReLex-SMILE is safe and effective method, since there is no flap and this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth.
At hyperopic residual refraction this study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant(-1.50D) that will be taken from myopic patients to implant on Pseudophakic patients with residual hypermetropia refraction (+1.0D) using VisuMax Femtosecond laser - Smile module surgery
- Conditions
- Pseudophakia, Myopia, Hyperopia
- Being tested
- Relex Smile, Relex smile with fresh corneal lenticule implantation
- Medical subject headings
- Pseudophakia, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relex SmileProcedure or surgery
Procedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was min -0.75D.The optical zone (lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker(ViscotMedster).
Relex smile with fresh corneal lenticule implantationProcedure or surgery
VisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule.
The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 4 mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.
In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticular implantation should be performed according to the low K values.
| Study group | Role | What they receive |
|---|---|---|
| ReLex Smile surgery | Other | The aim of this study is to investigate the effect of Relex Smile surgery to correct the residual refractive errors (myopic and hyperopic) 6 months after Trifocal IOL Implantation.
At myopic residual refraction (min -0.75 D) (100eyes) 6 months after Trifocal IOL Implantation we used Relex-Smile surgery for treatment. Receives: Procedure: Relex Smile |
| ReLex Smile surgery-fresh corneal lenticule implantation | Other | At hyperopic residual refraction 30 eyes 6 months after Trifocal IOL Implantation we used fresh corneal myopic lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients with residual hypermetropic refraction using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity. Receives: Procedure: Relex smile with fresh corneal lenticule implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of visual acuity
Increase of visual acuity by reducing residual refractive errors (myopia, hyperopia) using ReLex Smile after Trifocal IOL implantation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Jun 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudophakiaStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Myopic group 100 eyes hyperopic group 30 eyes
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT04712318
- Sponsor's protocol ID
- EHospitalPristina
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Succesful Treatment of Residual Refraction Errors (Myopic and Hyperopic) 6 Months After Trifocal IOL Implantation With Relex-Smile
- ClinicalTrials.gov ID
- NCT04712318
- Acronym / sponsor ID
- EHospitalPristina
- Conditions
- Pseudophakia, Myopia, Hyperopia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Eye Hospital Pristina KosovoUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Jan 2021 (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.
Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.
Detailed description
Residual refractive errors(myopia 50% and hyperopia 30%) are the main problems at patients after IOL Implantation.
The residual refraction (myopic and hyperopic) after IOL Implantation is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition.
Two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (RLE) and excimer laser ablation (LASIK or PRK).
Laser procedures: Photorefractive keratectomy (PRK); Laser assisted in situ keratomileusis (LASIK); Risks of LASIK include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of BCVA, infectious keratitis, symptoms, and diffuse lamellar keratitis.
Refractive lens exchange (RLE); The risks of RLE are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment.
The aim of our study is to investigate the effect of Relex-Smile to treat the residual refraction errors (myopia and hypermetropia) 6 months after IOL Implantation.
Before SMILE, Yag-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE ,there will be a diopter change. In pseudophakic patients with hyperopic astigmatism and residual refraction ,corneal topography-guided intrastromal fresh lenticular implantation should be performed and the lenticule was placed according to the low K value.
At myopic residual refraction(-0.75D till -5.50D) after IOL Implantation The method used at the EYE Hospital Pristina by ReLex-SMILE is safe and effective method, since there is no flap and this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth.
At hyperopic residual refraction this study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant(-1.50D) that will be taken from myopic patients to implant on Pseudophakic patients with residual hypermetropia refraction (+1.0D) using VisuMax Femtosecond laser - Smile module surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Myopic group 100 eyes hyperopic group 30 eyes
| Arm | Type | Receives |
|---|---|---|
| ReLex Smile surgery | Other | Procedure: Relex SmileThe aim of this study is to investigate the effect of Relex Smile surgery to correct the residual refractive errors (myopic and hyperopic) 6 months after Trifocal IOL Implantation. At myopic residual refraction (min -0.75 D) (100eyes) 6 months after Trifocal IOL Implantation we used Relex-Smile surgery for treatment. |
| ReLex Smile surgery-fresh corneal lenticule implantation | Other | Procedure: Relex smile with fresh corneal lenticule implantationAt hyperopic residual refraction 30 eyes 6 months after Trifocal IOL Implantation we used fresh corneal myopic lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients with residual hypermetropic refraction using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- residual hypermetropic, myopic refraction on pseudophakic patients
- low visual acuity
Key exclusion criteria (4 listed)
- active anterior segment pathologic features,
- previous corneal or anterior segment surgery,
- glaucoma,
- retinal detachment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relex SmileProcedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was min -0.75D.The optical zone (lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker(ViscotMedster). | Procedure or surgery | ReLex Smile surgery |
| Relex smile with fresh corneal lenticule implantationVisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule. The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 4 mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision. In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticular implantation should be performed according to the low K values. | Procedure or surgery | ReLex Smile surgery-fresh corneal lenticule implantation |
Primary outcome
Increase of visual acuity
Time frame: 6 months
Increase of visual acuity by reducing residual refractive errors (myopia, hyperopia) using ReLex Smile after Trifocal IOL implantation
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 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relex Smile and Relex smile with fresh corneal lenticule implantation in people with Pseudophakia and Myopia, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
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 2 inclusion and 4 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. 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?
Increase of visual acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.