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)
Primary Purpose
Cataract, Corneal Astigmatism, Corneal Incision Contracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally.
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.
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring surgically induced astigmatism, phacoemulsification, bimanual microincision cataract surgery, coaxial microincision cataract surgery, small incision cataract surgery, clear corneal incision
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
B-MICS 1.4 mm
C-MICS 1.8 mm
C-SICS 2.4 mm
Arm Description
bimanual 1.4 mm cataract surgery (B-MICS)
coaxial 1.8 mm cataract surgery (C-MICS)
coaxial 2.4 mm small incision cataract surgery (C-SICS)
Outcomes
Primary Outcome Measures
the best corrected visual acuity
examined with digital Snellen chart, measured in decimal scale
the best uncorrected visual acuity
examined with digital Snellen chart, measured in decimal scale
autorefractometry
measured in diopters (D)
keratometry
measured in diopters (D)
intraocular pressure (IOP)
measured in millimeters of mercury (mmHg)
endothelial cell density (ECD)
measured in endothelial cells/mm2
central corneal thickness (CCT)
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
peripheral temporal corneal thickness
measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
peripheral nasal corneal thickness
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
anterior chamber depth (ACD)
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
the white-to-white (WTW) distance - the horizontal corneal diameter
measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
length of the clear corneal incision
the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
anterior chamber angle
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
central foveal thickness (CFT)
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
parafoveal retinal thickness
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
Secondary Outcome Measures
surgically induced astigmatism SIA
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)
Full Information
NCT ID
NCT05510869
First Posted
August 18, 2022
Last Updated
August 19, 2022
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT05510869
Brief Title
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).
Acronym
MICS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Corneal Astigmatism, Corneal Incision Contracture
Keywords
surgically induced astigmatism, phacoemulsification, bimanual microincision cataract surgery, coaxial microincision cataract surgery, small incision cataract surgery, clear corneal incision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B-MICS 1.4 mm
Arm Type
Experimental
Arm Description
bimanual 1.4 mm cataract surgery (B-MICS)
Arm Title
C-MICS 1.8 mm
Arm Type
Active Comparator
Arm Description
coaxial 1.8 mm cataract surgery (C-MICS)
Arm Title
C-SICS 2.4 mm
Arm Type
Active Comparator
Arm Description
coaxial 2.4 mm small incision cataract surgery (C-SICS)
Intervention Type
Procedure
Intervention Name(s)
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
Intervention Description
microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
Intervention Type
Procedure
Intervention Name(s)
Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally.
Intervention Description
microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
Intervention Type
Procedure
Intervention Name(s)
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.
Intervention Description
small incision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
Primary Outcome Measure Information:
Title
the best corrected visual acuity
Description
examined with digital Snellen chart, measured in decimal scale
Time Frame
36 months
Title
the best uncorrected visual acuity
Description
examined with digital Snellen chart, measured in decimal scale
Time Frame
36 months
Title
autorefractometry
Description
measured in diopters (D)
Time Frame
36 months
Title
keratometry
Description
measured in diopters (D)
Time Frame
36 months
Title
intraocular pressure (IOP)
Description
measured in millimeters of mercury (mmHg)
Time Frame
36 months
Title
endothelial cell density (ECD)
Description
measured in endothelial cells/mm2
Time Frame
36 months
Title
central corneal thickness (CCT)
Description
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
Time Frame
36 months
Title
peripheral temporal corneal thickness
Description
measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
Time Frame
36 months
Title
peripheral nasal corneal thickness
Description
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
Time Frame
36 months
Title
anterior chamber depth (ACD)
Description
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
Time Frame
36 months
Title
the white-to-white (WTW) distance - the horizontal corneal diameter
Description
measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
Time Frame
36 months
Title
length of the clear corneal incision
Description
the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
Time Frame
36 months
Title
anterior chamber angle
Description
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
Time Frame
36 months
Title
central foveal thickness (CFT)
Description
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
Time Frame
36 months
Title
parafoveal retinal thickness
Description
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
surgically induced astigmatism SIA
Description
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)
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
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).
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