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Enrolling by invitationNCT04693663Relex-SmileUpdated Jul 29, 2026

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

An interventional study of Relex-Smile surgery in Pseudophakia and Myopia, sponsored by Eye Hospital Pristina Kosovo. Enrolling by invitation at 1 site in Kosovo. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Jun 2017, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Pseudophakia
  • Myopia
03

In context

Pseudophakia

54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.

This study's planned enrollment of 20 is below the median of 45 across 25 interventional studies indexed under Pseudophakia.

Browse Pseudophakia studies →

Lead sponsor

Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • residual myopic refraction -0.75d till -5.50D
  • complain visual acuity regarding residual myopic refraction

Exclusion criteria

Exclusion Criteria:

  • active anterior segment pathologic features
  • previous corneal or anterior segment surgery
  • glaucoma
  • history of ocular inflammation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    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).

    Procedure: Relex-Smile surgery

Interventions

  • ProcedureRelex-Smile surgery

    surgery using Relex-Smile

    Also known as: Relex smile surgery

06

What researchers measure

Primary outcomes

  1. Increase of visual acuity

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

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Publications

  • Semiz F, Lokaj AS, Musa NH, Semiz CE, Demirsoy ZA, Semiz O. SMILE for the Treatment of Residual Refractive Error After Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1539-1550. doi: 10.1007/s40123-022-00526-7. Epub 2022 May 28. PubMed 35643966 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04693663
Lead sponsor
Eye Hospital Pristina Kosovo
Responsible party
Dr. Faruk Semiz (Head of Ophthalmology Department, Eye Hospital Pristina Kosovo) — Principal investigator
First posted
Jan 5, 2021
Start date
Jun 1, 2017
Primary completion
Jun 1, 2018
Completion
Jun 1, 2027 (estimated)
Last update
Jul 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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