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).

Cataract Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510869
• Other study ID #: RNN/230/13/KE
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2022
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 87 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Contracture
• Corneal Astigmatism
• Surgical Wound

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the best corrected visual acuity	examined with digital Snellen chart, measured in decimal scale	36 months
Primary	the best uncorrected visual acuity	examined with digital Snellen chart, measured in decimal scale	36 months
Primary	autorefractometry	measured in diopters (D)	36 months
Primary	keratometry	measured in diopters (D)	36 months
Primary	intraocular pressure (IOP)	measured in millimeters of mercury (mmHg)	36 months
Primary	endothelial cell density (ECD)	measured in endothelial cells/mm2	36 months
Primary	central corneal thickness (CCT)	measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).	36 months
Primary	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
Primary	peripheral nasal corneal thickness	measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)	36 months
Primary	anterior chamber depth (ACD)	measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).	36 months
Primary	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
Primary	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
Primary	anterior chamber angle	measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees	36 months
Primary	central foveal thickness (CFT)	measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)	36 months
Primary	parafoveal retinal thickness	measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)	36 months
Secondary	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)	36 months