Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Study Overview
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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.

Official Title
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Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Conditions
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Hyperopia, High Astigmatism

Intervention / Treatment
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* Device: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Miopic Group Hyperopic Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FRESH CORNEAL LENTICULE IMPLANTATION<br>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<br>* Fresh Corneal Lenticule Implantation using ReLex-Smile<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of visual acuity, accommodation process | 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 | In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted. | 12 months |