Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04616144

Enrollment

Registered

2020-11-04

Start date

2019-05-01

Completion date

2027-05-01

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Astigmatism, Hyperopia

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.

Interventions

DEVICEFresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser

Fresh Corneal Lenticule Implantation using ReLex-Smile

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Miopic Group Hyperopic Group

Intervention model description

Miopic Group Hyperopic Group

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026