Clinical trial NCT04692012: Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Official title: Successful Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule Implantation with ReLex-Smile Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pseudophakia
Hypermetropia
Myopia
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pseudophakic group hyperopic group myopic group
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: increasing of visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References: