Biaxial Microincision Cataract Surgery Technique (BiMICS14vs18)

Analysis of Quality of Vision and Eye Tissue Complications in Patients Operated With Biaxial Microincision Surgery Technique.

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.

Study Overview

• Status: Unknown
• Conditions: Cataract Senile
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-093
    • Eyemed Centrum Okulistyczne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Snellen charts, EDTRS charts	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratometry	Diopters	3 months
Surgically Induced Astigmatism, SIA	Diopters	3 months
Higher Order Aberrations, HOAs	Micrones	3 months
Corneal Incision thickness	Micrones	3 nmonths

Collaborators and Investigators

• Sponsor: Eyemed Centrum Okulistyczne
• Investigators: Principal Investigator: Paweł Klonowski, MD, Eyemed Centrum Okulistyczne

Publications and helpful links

Helpful Links

• MICS and Incise IOL
• MICS and HOA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 12, 2018
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 29, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EYE0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: UCVA, BCVA, SIA, HOAs, Corneal Incision thickness
• IPD Sharing Time Frame: from August 2019 until December 2020
• IPD Sharing Access Criteria: only on request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Study Data/Documents

1. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No