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

Eye Hospital Pristina Kosovo

Status: Active, not recruiting

Conditions: Myopia; Pseudophakia; Hypermetropia

Treatments: Other: FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04692012

EHPristina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

FRESH CORNEAL LENTICULE IMPLANTATION

Other group

Description:

The aim of this study is to investigate the effect of fresh corneal myopic lenticule implantation as allogenic implant that will be taken from myopic patients to implant on pseudophakic patients with residual hypermetropic refraction using VisuMax Femtosecond Laser-Smile module surgery with primary objective to assess(increase) visual acuity.

Treatment:

Other: FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION