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

Not Applicable

• Conditions: Pseudophakia; Myopia
• Interventions: Procedure: Relex-Smile surgery

• Registration Number: NCT04693663
• Lead Sponsor: Eye Hospital Pristina Kosovo

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-06-01
• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReLex Smile surgery	Relex-Smile surgery	Procedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was 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 3.5 mm incision and marked with a sterile marker(Viscot-Medster).

Primary Outcome Measures

Name	Time	Method
Increase of visual acuity	6 months	Treatment of residual myopic refraction on Pseudophakic patients, was performed using ReLex Smile after 6 months.

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo