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Active Not Recruiting NCT04692012

Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule

Conditions: Pseudophakia, Hypermetropia, Myopia

Sex: All
Ages: 19 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 34
Sponsor: Eye Hospital Pristina Kosovo

Location: Eye Hospital Pristina Pristina

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.

Eligibility Criteria

Inclusion Criteria: * residual hypermetropic refraction on pseudophakic patients * low visual acuity Exclusion Criteria: * active anterior segment pathologic features, * previous corneal or anterior segment surgery, * glaucoma, * retinal detachment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04692012). StuddyBuddy aggregates publicly available trial information.