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).
- Conditions
- Corneal Incision ContractureCorneal AstigmatismCataract
- Interventions
- 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.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 supratemporallyProcedure: 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.
- Registration Number
- NCT05510869
- Lead Sponsor
- Medical University of Lodz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C-MICS 1.8 mm 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 1.8 mm cataract surgery (C-MICS) B-MICS 1.4 mm 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 bimanual 1.4 mm cataract surgery (B-MICS) C-SICS 2.4 mm 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. coaxial 2.4 mm small incision cataract surgery (C-SICS)
- Primary Outcome Measures
Name Time Method keratometry 36 months measured in diopters (D)
autorefractometry 36 months measured in diopters (D)
central corneal thickness (CCT) 36 months measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
peripheral nasal corneal thickness 36 months measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
the best uncorrected visual acuity 36 months examined with digital Snellen chart, measured in decimal scale
endothelial cell density (ECD) 36 months measured in endothelial cells/mm2
intraocular pressure (IOP) 36 months measured in millimeters of mercury (mmHg)
peripheral temporal corneal thickness 36 months measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
parafoveal retinal thickness 36 months measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
the best corrected visual acuity 36 months examined with digital Snellen chart, measured in decimal scale
anterior chamber depth (ACD) 36 months measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
length of the clear corneal incision 36 months the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
the white-to-white (WTW) distance - the horizontal corneal diameter 36 months measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
anterior chamber angle 36 months measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
central foveal thickness (CFT) 36 months measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
- Secondary Outcome Measures
Name Time Method surgically induced astigmatism SIA 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)