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).

Medical University of Lodz

Status: Completed

Conditions: Corneal Incision Contracture; Cataract; Corneal Astigmatism

Treatments: 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.; 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 supratemporally

Study type: Interventional

Funder types: Other

Identifiers

NCT05510869

RNN/230/13/KE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 35 to 87 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

B-MICS 1.4 mm

Experimental group

Description:

bimanual 1.4 mm cataract surgery (B-MICS)

Treatment:

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

C-MICS 1.8 mm

Active Comparator group

Description:

coaxial 1.8 mm cataract surgery (C-MICS)

Treatment:

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.

C-SICS 2.4 mm

Active Comparator group

Description:

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

Treatment:

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.