Myopia Clinical Trial - Treatment of Residual Hypermetropic Refraction on

Status Active, not recruiting

Clinical Trial Summary

The residual hypermetropic refraction on pseudophakic(Trifocal IOL) patients is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. Two current common surgeries to treat residual hyperopic refraction are refractive lens exchange (RLE) and excimer laser ablation (LASIK or PRK). Laser procedures: Photorefractive keratectomy (PRK); Laser assisted in situ keratomileusis (LASIK); Risks of LASIK include abnormalities of the corneal flap, epithelial ingrowth, corneal ectasia, refractive surprises, irregular astigmatism, decentration, visual aberrations, a loss of BCVA, infectious keratitis, symptoms, and diffuse lamellar keratitis. Refractive lens exchange (RLE); The risks of RLE are similar to those of cataract surgery and include endophthalmitis, a loss of accommodation, vitreous loss with posterior capsular rupture, and retinal detachment. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method, since there is no flap this prevents invasive damage to the anterior surface of the cornea contrary to the LASIK where flap is present posing risk for epithelial ingrowth. Before SMILE,YAG-laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG-laser is applied after the SMILE,there will be a diopter change.

Clinical Trial Description

This study is to investigate the effect of fresh myopic corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients(Trifocal IOL) with residual hypermetropic refraction(over +0.50Dsph) using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess (increase) visual acuity . In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticule implantation should be performed and the lenticule was placed according to the low K value. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04692012
Study type	Interventional
Source	Eye Hospital Pristina Kosovo
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 1, 2018
Completion date	January 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04923841` - Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine	N/A
Active, not recruiting	`NCT04080128` - Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control	N/A
Active, not recruiting	`NCT05275959` - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)	N/A
Completed	`NCT04604405` - Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation	N/A
Recruiting	`NCT05594719` - The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow	N/A
Completed	`NCT05594732` - The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow	N/A
Completed	`NCT04492397` - Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)	N/A
Completed	`NCT04536571` - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses	N/A
Completed	`NCT06046209` - Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens	N/A
Recruiting	`NCT06344572` - Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia	Phase 3
Recruiting	`NCT05611294` - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction	N/A
Completed	`NCT05656885` - Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses	N/A
Active, not recruiting	`NCT05534022` - Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.	N/A
Completed	`NCT03934788` - the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens	N/A
Completed	`NCT03701516` - Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2	N/A
Completed	`NCT05538754` - Post-Market Evaluation of the EVO ICL	N/A
Completed	`NCT03139201` - Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens	N/A
Completed	`NCT02555722` - Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear	N/A
Not yet recruiting	`NCT06009458` - Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear	N/A
Recruiting	`NCT05548478` - Corneal Endothelial Cell Injury Induced by Mitomycin-C	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule — ReLex-Smile

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms