Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

NCT04616144 | Active Not Recruiting

• 1 other identifier: EHospitalP
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperopia; High Astigmatism

Outcome Measures

Primary Outcomes (1)

• Increase of visual acuity, accommodation process

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

  12 months

Secondary Outcomes (1)

• Decrease of high hyperopic astigmatism

  12 months

Study Arms (1)

FRESH CORNEAL LENTICULE IMPLANTATION

OTHER

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.

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

Interventions

Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser DEVICE

Fresh Corneal Lenticule Implantation using ReLex-Smile

FRESH CORNEAL LENTICULE IMPLANTATION

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with high spherical hyperopia over + 4.5 D
• astigmatism over + 3 cyl.
• corneal thickness minimum 450 µm and maximum 550 µm.

You may not qualify if:

• corneal thickness over 550 µm
• history of glaucoma
• retinal detachment
• cataract
• history of ocular inflammation.

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Miopic Group Hyperopic Group
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: Miopic Group Hyperopic Group

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 4, 2020
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

KO (1)