Biaxial Microincision Cataract Surgery Technique | NCT03793101

Studies
Biaxial Microincision Cataract Surgery Technique

NCT03793101

Sponsor

Eyemed Centrum Okulistyczne

Status

Unknown status

Last Update Posted

Jan 4, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Cataract Senile

Interventions

BiMICS

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 12, 2018Actual

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Dec 29, 2018

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2019

Last Update Posted Date

Jan 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paweł Klonowski, Dr Paweł Klonowski Medical Director, Eyemed Centrum OkulistycznePrincipal Investigator

Lead Sponsor

Eyemed Centrum OkulistyczneOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BiMICS 1.4		Group 1.4 - Patients operated with 1.4 mm BiMICS technique	Procedure: BiMICS
BiMICS 1.8		Group 1.8 - Patients operated with 1.8 mm BiMICS technique	Procedure: BiMICS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BiMICS	Procedure	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Keratometry	Diopters	3 months
Surgically Induced Astigmatism, SIA	Diopters	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Clinical diagnose of senile cataract.

Exclusion Criteria:

Eye trauma in anamnesis.
Eye surgery in anamnesis.
Corneal surgery in anamnesis.
Corneal irregular astigmatism.
Corneal ectasia.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paweł Klonowski, MD	Eyemed Centrum Okulistyczne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eyemed Centrum Okulistyczne		Lublin		20-093	Poland

Label	URL
MICS and Incise IOL	View source

ID	Type	URL	Comment
	Clinical Study Report	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

UCVA, BCVA, SIA, HOAs, Corneal Incision thickness

Types

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