search
Back to results

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Primary Purpose

Hyperopia, High Astigmatism

Status
Active
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia

Eligibility Criteria

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

Inclusion Criteria:

  • patients with high spherical hyperopia over + 4.5 D
  • astigmatism over + 3 cyl.
  • corneal thickness minimum 450 µm and maximum 550 µm.

Exclusion Criteria:

  • corneal thickness over 550 µm
  • history of glaucoma
  • retinal detachment
  • cataract
  • history of ocular inflammation.

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 lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize(decrease) high astigmatism by reducing K values. Fresh corneal lenticule implantation as allogenic implant that we took from myopic patients (-5.0D) to implant in hyperopic patients (+4.0 D +3.0cyl) according to high K2 values. The stromal pocket diameter was 8 mm, 4mm super incision and 130-µm cap thickness.

Outcomes

Primary Outcome Measures

Increase of visual acuity, accommodation process
Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)

Secondary Outcome Measures

Decrease of high hyperopic astigmatism
In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.

Full Information

First Posted
October 26, 2020
Last Updated
September 5, 2023
Sponsor
Eye Hospital Pristina Kosovo
search

1. Study Identification

Unique Protocol Identification Number
NCT04616144
Brief Title
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Official Title
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 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 refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method. Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation (loss of accommodation, endophthalmitis). Its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. We believe this study will be the future of refractive surgery for treating high hyperopia.
Detailed Description
This study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess (increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize (decrease) high astigmatism by reducing K-values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, High Astigmatism

7. Study Design

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

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 lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize(decrease) high astigmatism by reducing K values. Fresh corneal lenticule implantation as allogenic implant that we took from myopic patients (-5.0D) to implant in hyperopic patients (+4.0 D +3.0cyl) according to high K2 values. The stromal pocket diameter was 8 mm, 4mm super incision and 130-µm cap thickness.
Intervention Type
Device
Intervention Name(s)
Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
Intervention Description
Fresh Corneal Lenticule Implantation using ReLex-Smile
Primary Outcome Measure Information:
Title
Increase of visual acuity, accommodation process
Description
Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Decrease of high hyperopic astigmatism
Description
In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with high spherical hyperopia over + 4.5 D astigmatism over + 3 cyl. corneal thickness minimum 450 µm and maximum 550 µm. Exclusion Criteria: corneal thickness over 550 µm history of glaucoma retinal detachment cataract history of ocular inflammation.
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

We'll reach out to this number within 24 hrs