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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Presbyopia
• Intervention / Treatment: Other: relex Smile module

Detailed Description

This study started at 2016 was performed in Eye Hospital Pristina in 82 eyes of 41 patients aged (40-50) with the emmetropic presbyopic complaint.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. We are shaping the surface of the cornea via an introstrımal pocket. We are using the SMILE module without removing the lenticule, and we are just separating the center of the cap from the top of lenticule In the short term, we have observed increases in spherical aberrations of patients. We also think that corneal shaping has an effect on the presbyopic correction. We will see and analyze the long-term effects by observing them.

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kosovo
  • Pristina, Kosovo, 10000
    • Eye Hospital Pristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patient not wishing to use glasses
• weak accomodation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: ReLex Smile module; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase of near visual acuity	Preparing an intrastromal pocket for emmetropic patients with near vision problems using the SMILE module.	12 months

Collaborators and Investigators

• Sponsor: Eye Hospital Pristina Kosovo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EyeHP 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No