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

NCT04692012 | Active Not Recruiting

• 1 other identifier: EHPristina
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudophakia; Hypermetropia; Myopia

Outcome Measures

Primary Outcomes (1)

• increasing of visual acuity

  using fresh myopic corneal lenticule for treatment of residual hypermetropic refraction on pseudophakic patients

  12 months

Study Arms (1)

FRESH CORNEAL LENTICULE IMPLANTATION

OTHER

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.

Other: FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION

Interventions

FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION OTHER

VisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule. The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 4 mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision. Incision position changed according to the position of the highest K values. Current orientation was marked with a sterile skin marker. The lenticule was positioned around the marked center of the cone and flattened out from the surface using a blunt spatula.

Also known as: Relex smile surgery

FRESH CORNEAL LENTICULE IMPLANTATION

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• residual hypermetropic refraction on pseudophakic patients
• low visual acuity

You may not qualify if:

• active anterior segment pathologic features,
• previous corneal or anterior segment surgery,
• glaucoma,
• retinal detachment

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Pseudophakia; Hyperopia; Myopia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: pseudophakic (Trifocal IOL) group 492 patients-246 eyes residual hyperopic group 34 patients-38 eyes
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: pseudophakic group hyperopic group myopic group

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

KO (1)