Evaluation of the Impact of Corneal Width on Surgically Induced Astigmatism (SIA) and Functional Results After Bimanual 1.4 mm Microincision Cataract Surgery (B-MICS), Coaxial 1.8 mm MICS (C-MICS) and 2.4 mm Small Incision Cataract Surgery (C-SICS). (MICS)

August 19, 2022 updated by: Magdalena Kucharczyk-Pośpiech, Medical University of Lodz

Comparison of Surgically Induced Astigmatism After Microincision Cataract Surgery (B-MICS 1.4 mm and C-MICS 1.8 mm) and C- SICS 2.4 mm

The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reduction of the width of the corneal incision was one the main changes taking place in cataract surgery in recent years. The common use of foldable intraocular lenses (IOLs) and technological development of phaco machines allowed to reduce clear corneal incision below 3 mm. Term of Microincision Cataract Surgery (MICS) understood as cataract phacoemulsification performed with the incision width below 2 mm was defined by professor Alio in 2003. However, despite various modifications introduced in recent years, phacoemulsification still causes damage of the tissues that results in surgically induced astigmatism.

Two MICS techniques have been developed: bimanual microincision cataract surgery (B-MICS) and coaxial microincision cataract surgery (C-MICS).

In the bimanual technique cataract phacoemulsification can be performed through the main incision 1.4 mm wide due to the usage of sleeveless phaco tip (without irrigation) and irrigation chopper. The advantage of separation the irrigation from aspiration is improvement of liquid dynamics in the anterior chamber. Moreover, due to the usage of the irrigation chopper, in B-MICS it is possible to lower the mean ultrasound energy.

In coaxial technique MICS phacoemulsification is performed through the incision 1.8 mm wide with usage of phaco tip with a silicon irrigation sleeve.

The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery. Moreover, this study aimed to evaluate the impact of corneal width on best corrected visual acuity (uncorrected and corrected), surgically induced astigmatism, endothelial cell loss, intraocular pressure, anterior segment of the eye and central retinal thickness.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 87 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lens opacities which were an indication for cataract surgery and absence of exclusion criteria,
  • cataract sclerosis grade from II to IV in Lens Opacities Classification System LOCS III scale (The Lens Opacities Classification System III).

Exclusion Criteria:

  • history of ocular surgery, ocular trauma,
  • congenital ocular malformations, amblyopia,
  • corneal disorders (including corneal opacities and scars),
  • best corrected visual acuity (BCVA) ≥ 0.9,
  • preoperative endothelial cell density <1500 cells/mm2,
  • history of uveitis, diabetic retinopathy,
  • retinal and macular disorders,
  • eventful phacoemulsification
  • presence of other diseases that could affect the postoperative visual outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B-MICS 1.4 mm
bimanual 1.4 mm cataract surgery (B-MICS)
Procedure: Bimanual 1.4 mm microincision cataract surgery (B-MICS) with IOL implantation in a "wound-assisted" technique. In bimanual MICS group a self-sealing 1.4 mm wide incision was created supratemporally
microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
ACTIVE_COMPARATOR: C-MICS 1.8 mm
coaxial 1.8 mm cataract surgery (C-MICS)
Procedure: Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally.
microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
ACTIVE_COMPARATOR: C-SICS 2.4 mm
coaxial 2.4 mm small incision cataract surgery (C-SICS)
Procedure: Coaxial 2.4 mm small incision cataract surgery (C-SICS) with IOL implantation with an injector through the 2.4 mm wide incision located temporally.
small incision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the best corrected visual acuity
Time Frame: 36 months
examined with digital Snellen chart, measured in decimal scale
36 months
the best uncorrected visual acuity
Time Frame: 36 months
examined with digital Snellen chart, measured in decimal scale
36 months
autorefractometry
Time Frame: 36 months
measured in diopters (D)
36 months
keratometry
Time Frame: 36 months
measured in diopters (D)
36 months
intraocular pressure (IOP)
Time Frame: 36 months
measured in millimeters of mercury (mmHg)
36 months
endothelial cell density (ECD)
Time Frame: 36 months
measured in endothelial cells/mm2
36 months
central corneal thickness (CCT)
Time Frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
36 months
peripheral temporal corneal thickness
Time Frame: 36 months
measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
36 months
peripheral nasal corneal thickness
Time Frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
36 months
anterior chamber depth (ACD)
Time Frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
36 months
the white-to-white (WTW) distance - the horizontal corneal diameter
Time Frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
36 months
length of the clear corneal incision
Time Frame: 36 months
the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
36 months
anterior chamber angle
Time Frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
36 months
central foveal thickness (CFT)
Time Frame: 36 months
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
36 months
parafoveal retinal thickness
Time Frame: 36 months
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgically induced astigmatism SIA
Time Frame: 36 months
measured in dioptres (D) - three different methods were used for calculation of surgically induced astigmatism (SIA): vector analysis method, vector decomposition method (C90), Naeser's polar values method (dKP-90)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (ACTUAL)

August 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/230/13/KE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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