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Completed

NCT Number: 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).

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.

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Key information

Age range

35 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Procedure

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.

Procedure

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

Primary outcomes

  1. the best corrected visual acuity

    Time frame: 36 months

    examined with digital Snellen chart, measured in decimal scale

  2. the best uncorrected visual acuity

    Time frame: 36 months

    examined with digital Snellen chart, measured in decimal scale

  3. autorefractometry

    Time frame: 36 months

    measured in diopters (D)

  4. keratometry

    Time frame: 36 months

    measured in diopters (D)

  5. intraocular pressure (IOP)

    Time frame: 36 months

    measured in millimeters of mercury (mmHg)

  6. endothelial cell density (ECD)

    Time frame: 36 months

    measured in endothelial cells/mm2

  7. central corneal thickness (CCT)

    Time frame: 36 months

    measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).

  8. peripheral temporal corneal thickness

    Time frame: 36 months

    measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)

  9. peripheral nasal corneal thickness

    Time frame: 36 months

    measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)

  10. anterior chamber depth (ACD)

    Time frame: 36 months

    measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).

  11. the white-to-white (WTW) distance - the horizontal corneal diameter

    Time frame: 36 months

    measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).

  12. length of the clear corneal incision

    Time frame: 36 months

    the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)

  13. anterior chamber angle

    Time frame: 36 months

    measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees

  14. central foveal thickness (CFT)

    Time frame: 36 months

    measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)

  15. parafoveal retinal thickness

    Time frame: 36 months

    measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)

Secondary outcomes

  1. surgically induced astigmatism SIA

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study 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

Acronym: MICS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2022
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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