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).

NCT ID: NCT05510869

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-05-01

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.

Conditions

Cataract; Corneal Astigmatism; Corneal Incision Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B-MICS 1.4 mm

bimanual 1.4 mm cataract surgery (B-MICS)

Group Type: EXPERIMENTAL

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 Type: PROCEDURE

microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb

C-MICS 1.8 mm

coaxial 1.8 mm cataract surgery (C-MICS)

Group Type: ACTIVE_COMPARATOR

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 Type: PROCEDURE

microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb

C-SICS 2.4 mm

coaxial 2.4 mm small incision cataract surgery (C-SICS)

Group Type: ACTIVE_COMPARATOR

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 Type: PROCEDURE

small incision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb

Interventions

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

Intervention Type: 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.

microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 87 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Magdalena Kucharczyk-Pośpiech

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

RNN/230/13/KE

Identifier Type: -

Identifier Source: org_study_id