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

Primary Purpose

Pseudophakia, Myopia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Relex-Smile surgery
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudophakia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ReLex Smile surgery

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 25, 2020
Last Updated
September 5, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT04693663
Brief Title
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Acronym
Relex-Smile
Official Title
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakia, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group consisting of 40 eyes
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ReLex Smile surgery
Arm Type
Other
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Relex-Smile surgery
Other Intervention Name(s)
Relex smile surgery
Intervention Description
surgery using Relex-Smile
Primary Outcome Measure Information:
Title
Increase of visual acuity
Description
Treatment of residual myopic refraction on Pseudophakic patients, was performed using ReLex Smile after 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35643966
Citation
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.
Results Reference
derived

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

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