NCT04692012: ReLex-Smile

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

Active, enrolled NA Last updated 25 February 2025

What this trial tests

NA trial testing FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION in Pseudophakia in 34 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2018

Primary endpoint
1 April 2020

1 February 2027

Quick facts

Lead sponsor	Eye Hospital Pristina Kosovo
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	1 April 2018
Primary completion	1 April 2020
Estimated completion	1 February 2027
Sites	1 location across Kosovo

Drugs / interventions tested

• FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION

Conditions studied

• Pseudophakia — all drugs for Pseudophakia →
• Hypermetropia — all drugs for Hypermetropia →
• Myopia — all drugs for Myopia →

Sponsor

Eye Hospital Pristina Kosovo

Who can join

Adults 19 to 50, any sex, with Pseudophakia or Hypermetropia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.