A New Successful Approach for Emmetropic Presbyopic Patients Using Intrastromal Pocket With Smile Module

NCT05115058 | Enrolling By Invitation

• 1 other identifier: EyeHP 1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Presbyopia is physiological insufficiency of accommodation associated with the aging of the eye that results in progressively worsening ability to focus clearly on close objects.Though presbyopia is a normal change in our eyes as we age, it often is a significant and emotional event because it's a sign of aging that's impossible to ignore and difficult to hide. This defect is usually corrected by using glasses with bifocal power of suitable focal lengths. But some patients don't want to use glasses for correction. In our study purpose is to show that near vision improves and patient satisfaction increases by preparing an intrastromal pocket for emmetropic patients with near vision problems using the SMILE module.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Increase of near visual acuity

  Preparing an intrastromal pocket for emmetropic patients with near vision problems using the SMILE module.

  12 months

Study Arms (1)

ReLex Smile module

OTHER

VisuMax femtosecond laser created the stromal pocket with a diameter 7.60 mm and cap thickness set to 120 μm from corneal surface and with a small opening - 2 mm superior incision at 90° and side cut angle 50°. The pocket was dissected using a blunt spatula. The patients were followed up for one year with distance, intermediate, and near visual acuity, slit lamp, corneal topography, anterior segment optical coherence tomography. Uncorrected near visual acuity at 35 cm increased from J7 to J2 in 8 eyes operated on, from J8 to J2 in 7 eyes, and from J6 to J2 in 6 eyes. Uncorrected intermediate visual acuity ranged from J4 to J5 at 70 cm, and uncorrected distance visual acuity remained binocular at 20/20. The patients reported satisfaction while reading a book, looking at the phone, and using a computer. No discomfort was observed from the lights while driving at night.

Other: relex Smile module

Interventions

relex Smile module OTHER

ReLex Smile module

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patient not wishing to use glasses
• weak accomodation

You may not qualify if:

• active anterior segment pathology
• previous corneal or anterior segment surgery
• any infection

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

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

Model Details: A New Successful Approach for Emmetropic Presbyopic Patients Using Intrastromal Pocket With Smile Module

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 10, 2021
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)