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NCT Number: NCT04616144

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hyperopia Eye Diseases High Astigmatism Refractive Errors

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital Pristina

Pristina, 10000, Kosovo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser

Device

Fresh Corneal Lenticule Implantation using ReLex-Smile

Primary outcomes

  1. Increase of visual acuity, accommodation process

    Time frame: 12 months

    Using fresh myopic corneal lenticule resulted in the increase of the visual acuity (far, intermediate and near vision)

Secondary outcomes

  1. Decrease of high hyperopic astigmatism

    Time frame: 12 months

    In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted.

Sponsors and collaborators

Lead sponsor

Eye Hospital Pristina Kosovo

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2026
First posted
Nov 4, 2020
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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