Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

NCT ID: NCT04616144

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2026-05-01

Brief Summary

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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

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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.

Conditions

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Hyperopia High Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Miopic Group Hyperopic Group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Miopic Group Hyperopic Group

Study Groups

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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.

Group Type OTHER

Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser

Intervention Type DEVICE

Fresh Corneal Lenticule Implantation using ReLex-Smile

Interventions

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Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser

Fresh Corneal Lenticule Implantation using ReLex-Smile

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye Hospital Pristina Kosovo

OTHER

Sponsor Role lead

Responsible Party

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Dr. Faruk Semiz

Head of Ophthalmology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Hospital Pristina

Pristina, , Kosovo

Site Status

Countries

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Kosovo

Other Identifiers

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EHospitalP

Identifier Type: -

Identifier Source: org_study_id

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