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Biaxial Microincision Cataract Surgery Technique (BiMICS14vs18)

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ClinicalTrials.gov Identifier: NCT03793101
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Paweł Klonowski, Eyemed Centrum Okulistyczne

Brief Summary:
To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.

Condition or disease Intervention/treatment
Cataract Senile Procedure: BiMICS

Detailed Description:
Modern trends in cataract surgery is the bimanual MICS technique. MICS significant development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision. This is not only a change in surgery technique, but it is a significant progress in safety and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract surgery by use dedicated MICS IOL`s. This allows to perform less traumatic surgery and provides the opportunity for fast visual rehabilitation from the first week after cataract surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique fully meet the requirements of modern refractive intraocular surgery.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Analysis of Quality of Vision and Eye Tissue Complications in Patients Operated With Biaxial Microincision Surgery Technique.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 12, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
BiMICS 1.4
Group 1.4 - Patients operated with 1.4 mm BiMICS technique
Procedure: BiMICS
Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.

BiMICS 1.8
Group 1.8 - Patients operated with 1.8 mm BiMICS technique
Procedure: BiMICS
Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.




Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 months ]
    Snellen charts, EDTRS charts


Secondary Outcome Measures :
  1. Keratometry [ Time Frame: 3 months ]
    Diopters

  2. Surgically Induced Astigmatism, SIA [ Time Frame: 3 months ]
    Diopters

  3. Higher Order Aberrations, HOAs [ Time Frame: 3 months ]
    Micrones

  4. Corneal Incision thickness [ Time Frame: 3 nmonths ]
    Micrones



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

1.Clinical diagnose of senile cataract.

Exclusion Criteria:

  1. Eye trauma in anamnesis.
  2. Eye surgery in anamnesis.
  3. Corneal surgery in anamnesis.
  4. Corneal irregular astigmatism.
  5. Corneal ectasia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793101


Locations
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Poland
Eyemed Centrum Okulistyczne
Lublin, Poland, 20-093
Sponsors and Collaborators
Eyemed Centrum Okulistyczne
Investigators
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Principal Investigator: Paweł Klonowski, MD Eyemed Centrum Okulistyczne

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

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Responsible Party: Paweł Klonowski, Dr Paweł Klonowski Medical Director, Eyemed Centrum Okulistyczne
ClinicalTrials.gov Identifier: NCT03793101     History of Changes
Other Study ID Numbers: EYE0001
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: UCVA, BCVA, SIA, HOAs, Corneal Incision thickness
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: from August 2019 until December 2020
Access Criteria: only on request
URL: http://eyemed.pl

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paweł Klonowski, Eyemed Centrum Okulistyczne:
BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases