ReLex-Smile: Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule

Sponsor
Eye Hospital Pristina Kosovo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04692012
Collaborator
(none)
34
1
1
72
0.5

Study Details

Study Description

Brief 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.

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pseudophakic group hyperopic group myopic grouppseudophakic group hyperopic group myopic group
Masking:
None (Open Label)
Masking Description:
pseudophakic (Trifocal IOL) group 492 patients-246 eyes residual hyperopic group 34 patients-38 eyes
Primary Purpose:
Treatment
Official Title:
Successful Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule Implantation With ReLex-Smile Surgery
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: FRESH CORNEAL LENTICULE IMPLANTATION

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.

Other: FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION
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.
Other Names:
  • Relex smile surgery
  • Outcome Measures

    Primary Outcome Measures

    1. increasing of visual acuity [12 months]

      using fresh myopic corneal lenticule for treatment of residual hypermetropic refraction on pseudophakic patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • residual hypermetropic refraction on pseudophakic patients

    • low visual acuity

    Exclusion Criteria:
    • active anterior segment pathologic features,

    • previous corneal or anterior segment surgery,

    • glaucoma,

    • retinal detachment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hospital Pristina Pristina Kosovo 10000

    Sponsors and Collaborators

    • Eye Hospital Pristina Kosovo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Faruk Semiz, Head of Ophthalmology Department, Eye Hospital Pristina Kosovo
    ClinicalTrials.gov Identifier:
    NCT04692012
    Other Study ID Numbers:
    • EHPristina
    First Posted:
    Dec 31, 2020
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021