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

Primary Purpose

Pseudophakia, Hypermetropia, Myopia

Status
Active
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudophakia

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FRESH CORNEAL LENTICULE IMPLANTATION

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 29, 2020
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT04692012
Brief Title
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Acronym
ReLex-Smile
Official Title
Successful Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule Implantation With ReLex-Smile Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakia, Hypermetropia, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pseudophakic 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
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FRESH CORNEAL LENTICULE IMPLANTATION
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION
Other Intervention Name(s)
Relex smile surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
increasing of visual acuity
Description
using fresh myopic corneal lenticule for treatment of residual hypermetropic refraction on pseudophakic patients
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

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Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule

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