Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05115058
Study type Interventional
Source Eye Hospital Pristina Kosovo
Contact
Status Enrolling by invitation
Phase N/A
Start date June 1, 2016
Completion date September 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT05326607 - Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia N/A
Recruiting NCT06060041 - IC-8 Apthera IOL New Enrollment Post Approval Study
Completed NCT05495971 - Extended Depth of Focus Contact Lenses for Presbyopia N/A
Completed NCT05464732 - Vivity IOL: Emmetropia Compared to Monovision. N/A
Recruiting NCT06045299 - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia Phase 3
Active, not recruiting NCT04151550 - Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines) N/A
Not yet recruiting NCT05506553 - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision N/A
Completed NCT02554396 - Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia Phase 2
Completed NCT02214797 - Dispensing Study to Assess Visual Performance of Prototype Contact Lenses N/A
Completed NCT02235831 - DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance N/A
Enrolling by invitation NCT01443585 - Clinical Evaluation of a Progressive Addition Lens (PAL) N/A
Completed NCT01591499 - Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal N/A
Completed NCT04983589 - A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily Phase 3
Completed NCT02740010 - The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Recruiting NCT05796453 - Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix N/A
Completed NCT02516306 - A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia Phase 1/Phase 2
Completed NCT05359380 - The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living
Not yet recruiting NCT04522427 - Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery N/A
Completed NCT03688425 - Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes N/A
Recruiting NCT06053463 - Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers N/A