Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery

NCT04793893 | Enrolling By Invitation

• 1 other identifier: EPristinaHospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors. Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Increase of visual acuity

  Increase of visual acuity by reducing residual hypermetropy refractive errors using ReLex Smile (human fresh lenticule implantation) after LASIK.

  12 months

Study Arms (1)

Treatment of residual hypermetropia refraction after LASIK

EXPERIMENTAL

The main problem at young patients post - LASIK after one year is residual hypermetropic refractive errors (especially accommodation problem) The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual hypermetropic refractive error (min. +1.0D). The flap of LASIk is lifted,cleaned and then the lenticule gently inserted.The lenticule was positioned according the K2 values when is astigmatism residual refractive error.In cases where is not astigmatism the lenticule was positioned in central position under the flap.

Device: ReLex Smile

Interventions

ReLex Smile DEVICE

With the ReLex Smile the optical zone (lenticule diameter) and cap diameter are 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule is extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker (ViscotMedster).

Treatment of residual hypermetropia refraction after LASIK

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• residual hypermetropic refraction,
• low visual acuity

You may not qualify if:

• active anterior segment pathology,
• glaucoma,
• retinae detachment,

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 11, 2021
• Study Start: January 8, 2019
• Primary Completion: January 8, 2020
• Study Completion: November 8, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)