Clinical trial NCT05510869: 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).
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the best corrected visual acuity
timeFrame: 36 months
measure: the best uncorrected visual acuity
timeFrame: 36 months
measure: autorefractometry
timeFrame: 36 months
measure: keratometry
timeFrame: 36 months
measure: intraocular pressure (IOP)
timeFrame: 36 months
measure: endothelial cell density (ECD)
timeFrame: 36 months
measure: central corneal thickness (CCT)
timeFrame: 36 months
measure: peripheral temporal corneal thickness
timeFrame: 36 months
measure: peripheral nasal corneal thickness
timeFrame: 36 months
measure: anterior chamber depth (ACD)
timeFrame: 36 months
measure: the white-to-white (WTW) distance - the horizontal corneal diameter
timeFrame: 36 months
measure: length of the clear corneal incision
timeFrame: 36 months
measure: anterior chamber angle
timeFrame: 36 months
measure: central foveal thickness (CFT)
timeFrame: 36 months
measure: parafoveal retinal thickness
timeFrame: 36 months
Secondary outcomes:
measure: surgically induced astigmatism SIA
timeFrame: 36 months
Other outcomes:
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