Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

September 5, 2023 updated by: Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kosovo
      • Pristina, Kosovo, 10000
        • Eye Hospital Pristina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FRESH CORNEAL LENTICULE IMPLANTATION
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.
Device: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
Fresh Corneal Lenticule Implantation using ReLex-Smile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of visual acuity, accommodation process
Time Frame: 12 months
Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of high hyperopic astigmatism
Time Frame: 12 months
In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye Hospital Pristina Kosovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHospitalP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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