- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793893
Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery (Relex-Smile)
Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation Using Relex Smile Surgery
LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.
Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main problem at young patients post - LASIK after one year is residual refractive errors.
The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).
- The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.
- The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pristina, Kosovo, 10000
- Eye Hospital Pristina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- residual hypermetropic refraction,
- low visual acuity
Exclusion Criteria:
- active anterior segment pathology,
- glaucoma,
- retinae detachment,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment of residual hypermetropia refraction after LASIK
The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D). The flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap. |
With the ReLex Smile the optical zone (lenticule diameter) and cap diameter are 6.5 and 7.5 mm respectively.
After dissection of both anterior and posterior planes, the lenticule is extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker (ViscotMedster).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase of visual acuity
Time Frame: 12 months
|
Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPristinaHospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractive Errors
-
Suzan A RattanCompletedRefractive Errors | Refractive SurgeryIraq
-
London School of Hygiene and Tropical MedicineBritish Council for Prevention of Blindness; Tanzanian Society for the BlindCompletedUnder- and Uncorrected Significant Refractive ErrorsTanzania
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Alcon ResearchCompletedRefractive ErrorsUnited States
-
Alcon ResearchCompletedRefractive ErrorsUnited States
-
Alcon ResearchCompletedRefractive ErrorsUnited States
-
Ohio State UniversityNational Eye Institute (NEI); University of HoustonCompleted
-
Coopervision, Inc.Completed
Clinical Trials on ReLex Smile
-
Eye Hospital Pristina KosovoEnrolling by invitationMyopia | PseudophakiaKosovo
-
Eye Hospital Pristina KosovoEnrolling by invitationStromal KeratitisKosovo
-
Eye Hospital Pristina KosovoEnrolling by invitationMyopia | Hyperopia | PseudophakiaKosovo
-
Carl Zeiss Meditec AGUnknownHypermetropiaChina, Czechia, France, Germany, India, United Kingdom
-
Eye Hospital Pristina KosovoActive, not recruitingKeratoconus | Keratoconus of Right Eye | Keratoconus, Unstable, Right EyeKosovo
-
Tilganga Institute of OphthalmologyLondon Vision ClinicUnknown
-
Eye Hospital Pristina KosovoEnrolling by invitation
-
Eye Hospital Pristina KosovoActive, not recruitingAdenoviral KeratoconjunctivitisKosovo
-
Eye Hospital Pristina KosovoEnrolling by invitationProgressive Disease of CorneaeKosovo
-
Eye Hospital Pristina KosovoEnrolling by invitationMacular Corneal DystrophyKosovo