Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Eye Hospital Pristina Kosovo

Status: Active, not recruiting

Conditions: High Astigmatism; Hyperopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04616144

EHospitalP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

FRESH CORNEAL LENTICULE IMPLANTATION

Other group

Description:

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.

Treatment:

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