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NCT04693663 Clinical Trial

Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile

Myopia Clinical Trial

— Relex-Smile  

Official title:
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04693663
Other study ID # EHP
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date June 1, 2024

Study information
Verified date September 2023
Source Eye Hospital Pristina Kosovo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to assess visual and refractive outcomes after laser vision correction (LVC) - ReLex Smile to correct residual myopic refraction after 6 months of pseudophakic (IOL) implantation. Before SMILE YAG-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE, there will be a diopter change.

Description:

The residual myopic refraction after 6 month on pseudophakic patients using Relex-Smile surgery using VisuMax Femtosecond Laser.The residual myopic refractive power is between -0.75D till -5.50D.The optical zone(lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively.After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5mm incision and marked with a sterile marker(Viscot-Medster)

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date June 1, 2024
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - residual myopic refraction -0.75d till -5.50D - complain visual acuity regarding residual myopic refraction Exclusion Criteria: - active anterior segment pathologic features - previous corneal or anterior segment surgery - glaucoma - history of ocular inflammation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Relex-Smile surgery
surgery using Relex-Smile

Locations
Country Name City State
Kosovo Eye Hospital Pristina Pristina

Sponsors (1)
Lead Sponsor Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase of visual acuity Treatment of residual myopic refraction on Pseudophakic patients, was performed using ReLex Smile after 6 months. 6 months
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