Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Not Applicable

Active, not recruiting

• Conditions: High Astigmatism; Hyperopia
• Interventions: Device: Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser

• Registration Number: NCT04616144
• Lead Sponsor: Eye Hospital Pristina Kosovo

Brief 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.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2020-05-01
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FRESH CORNEAL LENTICULE IMPLANTATION	Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser	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.

Primary Outcome Measures

Name	Time	Method
Increase of visual acuity, accommodation process	12 months	Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)

Secondary Outcome Measures

Name	Time	Method
Decrease of high hyperopic astigmatism	12 months	In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo