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

• Sponsor: Eye Hospital Pristina Kosovo (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05115058
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Other: relex Smile module	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A New Successful Approach for Emmetropic Presbyopic Patients Using Intrastromal Pocket With Smile ModuleA New Successful Approach for Emmetropic Presbyopic Patients Using Intrastromal Pocket With Smile Module
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A New Successful Approach for Emmetropic Presbyopic Patients Using Intrastromal Pocket With Smile Module
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jun 1, 2018
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Increase of near visual acuity [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient not wishing to use glasses

• weak accomodation

Exclusion Criteria:

• active anterior segment pathology

• previous corneal or anterior segment surgery

• any infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital Pristina	Pristina		Kosovo	10000

Sponsors and Collaborators

• Eye Hospital Pristina Kosovo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Faruk Semiz, Head of Ophthalmology Department, Eye Hospital Pristina Kosovo
• ClinicalTrials.gov Identifier: NCT05115058
• Other Study ID Numbers: EyeHP 1
• First Posted: Nov 10, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Nov 10, 2021