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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693663
Acronym
Relex-Smile
Enrollment
20
Registered
2021-01-05
Start date
2017-06-01
Completion date
2027-06-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Pseudophakia

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)

Interventions

PROCEDURERelex-Smile surgery

surgery using Relex-Smile

Sponsors

Eye Hospital Pristina Kosovo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

One group consisting of 40 eyes

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Increase of visual acuity6 monthsTreatment of residual myopic refraction on Pseudophakic patients, was performed using ReLex Smile after 6 months.

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026