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).

• Sponsor: Medical University of Lodz (Other)
• Overall Status: Completed
• CT.gov ID: NCT05510869
• Collaborator: (none)
• Enrollment: 90
• Arms: 3
• Actual Duration (Months): 40

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Corneal Astigmatism; Corneal Incision Contracture	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; 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: 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.	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B-MICS 1.4 mm bimanual 1.4 mm cataract surgery (B-MICS)	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
Active Comparator: C-MICS 1.8 mm coaxial 1.8 mm cataract surgery (C-MICS)	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
Active Comparator: C-SICS 2.4 mm coaxial 2.4 mm small incision cataract surgery (C-SICS)	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

Outcome Measures

Primary Outcome Measures

1. the best corrected visual acuity [36 months]

   examined with digital Snellen chart, measured in decimal scale

2. the best uncorrected visual acuity [36 months]

   examined with digital Snellen chart, measured in decimal scale

3. autorefractometry [36 months]

   measured in diopters (D)

4. keratometry [36 months]

   measured in diopters (D)

5. intraocular pressure (IOP) [36 months]

   measured in millimeters of mercury (mmHg)

6. endothelial cell density (ECD) [36 months]

   measured in endothelial cells/mm2

7. central corneal thickness (CCT) [36 months]

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

8. peripheral temporal corneal thickness [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 [36 months]

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

10. anterior chamber depth (ACD) [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 [36 months]

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

12. length of the clear corneal incision [36 months]

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

13. anterior chamber angle [36 months]

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

14. central foveal thickness (CFT) [36 months]

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

15. parafoveal retinal thickness [36 months]

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

Secondary Outcome Measures

1. surgically induced astigmatism SIA [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 87 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical University of Lodz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magdalena Kucharczyk-Pośpiech, Principal Investigator, Medical University of Lodz
• ClinicalTrials.gov Identifier: NCT05510869
• Other Study ID Numbers: RNN/230/13/KE
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Magdalena Kucharczyk-Pośpiech, Principal Investigator, Medical University of Lodz: surgically induced astigmatism; phacoemulsification; bimanual microincision cataract surgery; coaxial microincision cataract surgery; small incision cataract surgery; clear corneal incision
• Additional relevant MeSH terms: Contracture; Cataract; Astigmatism; Surgical Wound

Study Results

No Results Posted as of Aug 22, 2022