Biaxial Microincision Cataract Surgery Technique

Cataract Senile Clinical Trial

— BiMICS14vs18  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03793101
• Other study ID #: EYE0001
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Eyemed Centrum Okulistyczne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

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.

Locations

Country	Name	City	State
Poland	Eyemed Centrum Okulistyczne	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Eyemed Centrum Okulistyczne

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Snellen charts, EDTRS charts	3 months
Secondary	Keratometry	Diopters	3 months
Secondary	Surgically Induced Astigmatism, SIA	Diopters	3 months
Secondary	Higher Order Aberrations, HOAs	Micrones	3 months
Secondary	Corneal Incision thickness	Micrones	3 nmonths

External Links

•   MICS and HOA
•   MICS and Incise IOL