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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Astigmatism
• High Astigmatism
• Hyperopia

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