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
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
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedAugust 22, 2022
August 1, 2022
3 years
August 18, 2022
August 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
the best corrected visual acuity
examined with digital Snellen chart, measured in decimal scale
36 months
the best uncorrected visual acuity
examined with digital Snellen chart, measured in decimal scale
36 months
autorefractometry
measured in diopters (D)
36 months
keratometry
measured in diopters (D)
36 months
intraocular pressure (IOP)
measured in millimeters of mercury (mmHg)
36 months
endothelial cell density (ECD)
measured in endothelial cells/mm2
36 months
central corneal thickness (CCT)
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
36 months
peripheral temporal corneal thickness
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
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
36 months
anterior chamber depth (ACD)
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
36 months
the white-to-white (WTW) distance - the horizontal corneal diameter
measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
36 months
length of the clear corneal incision
the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
36 months
anterior chamber angle
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
36 months
central foveal thickness (CFT)
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
36 months
parafoveal retinal thickness
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
36 months
Secondary Outcomes (1)
surgically induced astigmatism SIA
36 months
Study Arms (3)
B-MICS 1.4 mm
EXPERIMENTALbimanual 1.4 mm cataract surgery (B-MICS)
C-MICS 1.8 mm
ACTIVE COMPARATORcoaxial 1.8 mm cataract surgery (C-MICS)
C-SICS 2.4 mm
ACTIVE COMPARATORcoaxial 2.4 mm small incision cataract surgery (C-SICS)
Interventions
microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb
microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb
small incision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb
Eligibility Criteria
You may not qualify if:
- cataract sclerosis grade from II to IV in Lens Opacities Classification System LOCS III scale (The Lens Opacities Classification System III).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 18, 2022
First Posted
August 22, 2022
Study Start
January 1, 2016
Primary Completion
January 1, 2019
Study Completion
May 1, 2019
Last Updated
August 22, 2022
Record last verified: 2022-08