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NCT04616144 Clinical Trial

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Hyperopia Clinical Trial

Official title:
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04616144
Other study ID # EHospitalP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date May 1, 2024

Study information
Verified date September 2023
Source Eye Hospital Pristina Kosovo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 55
Est. completion date May 1, 2024
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser
Fresh Corneal Lenticule Implantation using ReLex-Smile

Locations
Country Name City State
Kosovo Eye Hospital Pristina Pristina

Sponsors (1)
Lead Sponsor Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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