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Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery (Relex-Smile)

Primary Purpose

Refractive Errors

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
ReLex Smile
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • residual hypermetropic refraction,
  • low visual acuity

Exclusion Criteria:

  • active anterior segment pathology,
  • glaucoma,
  • retinae detachment,

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of residual hypermetropia refraction after LASIK

Arm Description

The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D). The flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap.

Outcomes

Primary Outcome Measures

Increase of visual acuity
Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2021
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT04793893
Brief Title
Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery
Acronym
Relex-Smile
Official Title
Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation Using Relex Smile Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
December 8, 2023 (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
LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors. Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)
Detailed Description
The main problem at young patients post - LASIK after one year is residual refractive errors. The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D). The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap. The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment of residual hypermetropia refraction after LASIK
Arm Type
Experimental
Arm Description
The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D). The flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap.
Intervention Type
Device
Intervention Name(s)
ReLex Smile
Intervention Description
With the ReLex Smile the optical zone (lenticule diameter) and cap diameter are 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule is extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker (ViscotMedster).
Primary Outcome Measure Information:
Title
Increase of visual acuity
Description
Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: residual hypermetropic refraction, low visual acuity Exclusion Criteria: active anterior segment pathology, glaucoma, retinae detachment,
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery

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