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

NCT ID: NCT04693663

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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)

Conditions

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Pseudophakia Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One group consisting of 40 eyes
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Relex-Smile surgery

Intervention Type PROCEDURE

surgery using Relex-Smile

Interventions

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Relex-Smile surgery

surgery using Relex-Smile

Intervention Type PROCEDURE

Other Intervention Names

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Relex smile surgery

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye Hospital Pristina Kosovo

OTHER

Sponsor Role lead

Responsible Party

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Dr. Faruk Semiz

Head of Ophthalmology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Hospital Pristina

Pristina, , Kosovo

Site Status

Countries

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Kosovo

References

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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.

Reference Type DERIVED
PMID: 35643966 (View on PubMed)

Other Identifiers

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EHP

Identifier Type: -

Identifier Source: org_study_id

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