Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04616144
Other study ID # EHospitalP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date May 1, 2024

Study information

Verified date September 2023
Source Eye Hospital Pristina Kosovo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 55
Est. completion date May 1, 2024
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Kosovo Eye Hospital Pristina Pristina

Sponsors (1)

Lead Sponsor Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Decrease of high hyperopic astigmatism In order to stabilize high hyperopic astigmatism and reduce K-values, the myopic fresh corneal lenticule was implanted. 12 months
See also
  Status Clinical Trial Phase
Completed NCT06046209 - Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens N/A
Completed NCT05656885 - Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT01392950 - Clinical Study of Clariti Monthly Contact Lens N/A
Withdrawn NCT00765960 - Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure
Completed NCT00520689 - Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens Phase 3
Completed NCT05538182 - Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children N/A
Enrolling by invitation NCT05976750 - Air Optix® Night and Day® Aqua Daily Wear
Completed NCT02575911 - Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study N/A
Completed NCT05735990 - Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
Withdrawn NCT03671096 - Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction N/A
Recruiting NCT02279446 - Development of a Validated Chart for Intermediate Vision Assessment N/A
Completed NCT01951573 - Evaluation of a New Daily Disposable Multifocal Contact Lens Design N/A
Completed NCT02060539 - Multicenter Dispensing Study of Biofinity Lenses in Extended Range N/A
Completed NCT01467557 - Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY
Completed NCT01228591 - Pilot Dispensing Evaluation of a Plus Power Lens N/A
Completed NCT03722784 - Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear N/A
Completed NCT03688672 - Apioc Contact Lens Feasibility N/A
Completed NCT05741450 - A Clinical Comparison of Two Soft Contact Lenses N/A
Completed NCT01912781 - Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers N/A