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Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Sponsor
Eye Hospital Pristina Kosovo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04616144
Collaborator
(none)
55
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Miopic Group Hyperopic GroupMiopic Group Hyperopic Group
Masking:
None (Open Label)
Masking Description:
Miopic Group Hyperopic Group
Primary Purpose:
Treatment
Official Title:
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
May 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 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

Outcome Measures

Primary Outcome Measures

  1. Increase of visual acuity, accommodation process [12 months]

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

Secondary Outcome Measures

  1. Decrease of high hyperopic astigmatism [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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:
NCT04616144
Other Study ID Numbers:
  • EHospitalP
First Posted:
Nov 4, 2020
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Astigmatism
Hyperopia

Study Results

No Results Posted as of Jul 28, 2022