Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Relex-Smile surgery.
- Who it may be relevant to
- Registry conditions: Pseudophakia, Myopia. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kosovo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Relex-Smile surgery
surgery using Relex-Smile
Primary outcome measures
- Increase of visual acuity [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kosovo · 1 center
- Eye Hospital Pristina — Pristina
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. PMID 35643966
Identifiers
NCT: NCT04693663 · EHP