CataractMICSNCT05510869
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).
A study testing 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, Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally. and 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. in people with Cataract and Corneal Astigmatism, run by Medical University of Lodz.
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. Read more about this study
- Who is it for?
- Ages 35 to 87 years
- Conditions the study is for
- Cataract, Corneal Astigmatism, Corneal Incision Contracture
- What is being tested?
- 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, Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally. and 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.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
Show all 9Show fewer
- retinal and macular disorders,
- eventful phacoemulsification
- presence of other diseases that could affect the postoperative visual outcomes.
About this study
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
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.
Read the 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
- Being tested
- 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, Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally., 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.
- Keywords
- surgically induced astigmatism, phacoemulsification, bimanual microincision cataract surgery, coaxial microincision cataract surgery, small incision cataract surgery, clear corneal incision
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 supratemporallyProcedure or surgery
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 or surgery
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 or surgery
small incision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb
| Study group | Role | What they receive |
|---|---|---|
| B-MICS 1.4 mm | Experimental | bimanual 1.4 mm cataract surgery (B-MICS) Receives: 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 | coaxial 1.8 mm cataract surgery (C-MICS) Receives: 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 | coaxial 2.4 mm small incision cataract surgery (C-SICS) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the best corrected visual acuity
examined with digital Snellen chart, measured in decimal scale
Measured: 36 months
the best uncorrected visual acuity
examined with digital Snellen chart, measured in decimal scale
Measured: 36 months
autorefractometry
measured in diopters (D)
Measured: 36 months
keratometry
measured in diopters (D)
Measured: 36 months
intraocular pressure (IOP)
measured in millimeters of mercury (mmHg)
Measured: 36 months
endothelial cell density (ECD)
measured in endothelial cells/mm2
Measured: 36 months
central corneal thickness (CCT)
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
Measured: 36 months
peripheral temporal corneal thickness
measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
Measured: 36 months
peripheral nasal corneal thickness
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
Measured: 36 months
anterior chamber depth (ACD)
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
Measured: 36 months
the white-to-white (WTW) distance - the horizontal corneal diameter
measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
Measured: 36 months
length of the clear corneal incision
the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
Measured: 36 months
anterior chamber angle
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
Measured: 36 months
central foveal thickness (CFT)
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
Measured: 36 months
parafoveal retinal thickness
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
Measured: 36 months
Secondary outcomes (1)
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)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jan 2016
- Primary completion1 Jan 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Kucharczyk-Pośpiech, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510869
- Sponsor's protocol ID
- RNN/230/13/KE
- Acronym
- MICS
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05510869
- Acronym / sponsor ID
- MICS / RNN/230/13/KE
- Conditions
- Cataract, Corneal Astigmatism, Corneal Incision Contracture
- Keywords
- surgically induced astigmatism, phacoemulsification, bimanual microincision cataract surgery, coaxial microincision cataract surgery, small incision cataract surgery, clear corneal incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B-MICS 1.4 mm | Experimental | 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 supratemporallybimanual 1.4 mm cataract surgery (B-MICS) |
| C-MICS 1.8 mm | Active comparator | 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.coaxial 1.8 mm cataract surgery (C-MICS) |
| C-SICS 2.4 mm | Active comparator | 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.coaxial 2.4 mm small incision cataract surgery (C-SICS) |
Who may qualify
- Ages
- 35 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 supratemporallymicroincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch \& Lomb | Procedure or surgery | B-MICS 1.4 mm |
| 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 | Procedure or surgery | C-MICS 1.8 mm |
| 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 | Procedure or surgery | C-SICS 2.4 mm |
Primary outcome
the best corrected visual acuity
Time frame: 36 months
examined with digital Snellen chart, measured in decimal scale
the best uncorrected visual acuity
Time frame: 36 months
examined with digital Snellen chart, measured in decimal scale
autorefractometry
Time frame: 36 months
measured in diopters (D)
keratometry
Time frame: 36 months
measured in diopters (D)
intraocular pressure (IOP)
Time frame: 36 months
measured in millimeters of mercury (mmHg)
endothelial cell density (ECD)
Time frame: 36 months
measured in endothelial cells/mm2
central corneal thickness (CCT)
Time frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
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)
peripheral nasal corneal thickness
Time frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
anterior chamber depth (ACD)
Time frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
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).
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)
anterior chamber angle
Time frame: 36 months
measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
central foveal thickness (CFT)
Time frame: 36 months
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
parafoveal retinal thickness
Time frame: 36 months
measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
1 secondary outcome
surgically induced astigmatism SIA
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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, Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally. and 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. in people with Cataract and Corneal Astigmatism, run by Medical University of Lodz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the best corrected visual acuity (time frame: 36 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.