PseudophakiaReLex-SmileNCT04692012
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
A study testing FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION in people with Pseudophakia and Hypermetropia, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial summary
The residual hypermetropic refraction on pseudophakic(Trifocal IOL) patients 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 19 to 50 years
- Conditions the study is for
- Pseudophakia, Hypermetropia, Myopia
- What is being tested?
- FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Apr 2018to 1 Feb 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- residual hypermetropic 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.
About this study
Official title: Successful Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule Implantation With ReLex-Smile Surgery
The residual hypermetropic refraction on pseudophakic(Trifocal IOL) patients 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).
Read more
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 method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method, since there is no flap this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth.
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.
Read the detailed description
This study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients(Trifocal IOL) with residual hypermetropic refraction(over +0.50Dsph) using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess (increase) visual acuity . In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticule implantation should be performed and the lenticule was placed according to the low K value.
- Conditions
- Pseudophakia, Hypermetropia, Myopia
- Being tested
- FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION
- Medical subject headings
- Pseudophakia, Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRESH CORNEAL MYOPIC LENTICULE IMPLANTATIONOther
Also called Relex smile 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. Incision position changed according to the position of the highest K values. Current orientation was marked with a sterile skin marker. The lenticule was positioned around the marked center of the cone and flattened out from the surface using a blunt spatula.
| Study group | Role | What they receive |
|---|---|---|
| FRESH CORNEAL LENTICULE IMPLANTATION | Other | The aim of this study is to investigate the effect of 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: Other: FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
increasing of visual acuity
using fresh myopic corneal lenticule for treatment of residual hypermetropic refraction on pseudophakic patients
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 posted31 Dec 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Feb 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
- Not applicable
- Intervention model
- Single group
- Model description
- pseudophakic group hyperopic group myopic group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
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
- NCT04692012
- Sponsor's protocol ID
- EHPristina
- Acronym
- ReLex-Smile
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No