NCT04616144

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Eye Hospital Pristina Kosovo · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hyperopia
• High Astigmatism

Interventions

Type	Name	Description
DEVICE	Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser	Fresh Corneal Lenticule Implantation using ReLex-Smile

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-05-01
• Completion: 2026-05-01
• First posted: 2020-11-04
• Last updated: 2024-08-27

Locations

1 site across 1 country: Kosovo