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

NCT04693663 | Enrolling By Invitation

• 1 other identifier: EHP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudophakia; Myopia

Outcome Measures

Primary Outcomes (1)

• Increase of visual acuity

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

  6 months

Study Arms (1)

ReLex Smile surgery

OTHER

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

Relex-Smile surgery PROCEDURE

surgery using Relex-Smile

Also known as: Relex smile surgery

ReLex Smile surgery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pseudophakia; Myopia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: One group consisting of 40 eyes

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: January 5, 2021
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

KO (1)