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

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.

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Key information

Conditions

Pseudophakia Eye Diseases Myopia Pathological Conditions, Signs and Symptoms Refractive Errors Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital Pristina

Pristina, 10000, Kosovo

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relex-Smile surgery

Procedure

surgery using Relex-Smile

Other names: Relex smile surgery

Primary outcomes

Increase of visual acuity

Time frame: 6 months

Treatment of residual myopic refraction on Pseudophakic patients, was performed using ReLex Smile after 6 months.

Sponsors and collaborators

Lead sponsor

Eye Hospital Pristina Kosovo

Other

Registry information

Acronym: Relex-Smile

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2026
First posted: Jan 5, 2021
Registry last updated: Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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