Cataract SenileBiMICS14vs18NCT03793101
Biaxial Microincision Cataract Surgery Technique
An observational study of Cataract Senile, run by Eyemed Centrum Okulistyczne at 1 site in Poland.
Trial summary
To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract Senile
- What is being tested?
- BiMICS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community sample
Who may be able to join
- 1.Clinical diagnose of senile cataract.
Who cannot join
- Eye trauma in anamnesis.
- Eye surgery in anamnesis.
- Corneal surgery in anamnesis.
- Corneal irregular astigmatism.
- Corneal ectasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Quality of Vision and Eye Tissue Complications in Patients Operated With Biaxial Microincision Surgery Technique.
To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.
Read the detailed description
Modern trends in cataract surgery is the bimanual MICS technique. MICS significant development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision. This is not only a change in surgery technique, but it is a significant progress in safety and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and provides the opportunity for fast visual rehabilitation from the first week after cataract surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique fully meet the requirements of modern refractive intraocular surgery.
- Conditions
- Cataract Senile
- Being tested
- BiMICS
- Keywords
- BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiMICSProcedure or surgery
Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.
| Study group | Role | What they receive |
|---|---|---|
| BiMICS 1.4 | Group 1.4 - Patients operated with 1.4 mm BiMICS technique Receives: Procedure: BiMICS | |
| BiMICS 1.8 | Group 1.8 - Patients operated with 1.8 mm BiMICS technique Receives: Procedure: BiMICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Snellen charts, EDTRS charts
Measured: 3 months
Secondary outcomes (4)
Keratometry
Diopters
Measured: 3 months
Surgically Induced Astigmatism, SIA
Diopters
Measured: 3 months
Higher Order Aberrations, HOAs
Micrones
Measured: 3 months
Corneal Incision thickness
Micrones
Measured: 3 nmonths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jan 2018
- Primary completion12 Dec 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyemed Centrum Okulistyczne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Klonowski, Eyemed Centrum Okulistyczne
- Investigators
- Paweł Klonowski, MD, Principal investigator, Eyemed Centrum Okulistyczne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793101
- Sponsor's protocol ID
- EYE0001
- Acronym
- BiMICS14vs18
- Status last verified
- Jan 2019
- First submitted
- 29 Dec 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: UCVA, BCVA, SIA, HOAs, Corneal Incision thickness
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Quality of Vision and Eye Tissue Complications in Patients Operated With Biaxial Microincision Surgery Technique.
- ClinicalTrials.gov ID
- NCT03793101
- Acronym / sponsor ID
- BiMICS14vs18 / EYE0001
- Conditions
- Cataract Senile
- Keywords
- BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eyemed Centrum OkulistyczneUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Jan 2019 (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.
To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.
Detailed description
Modern trends in cataract surgery is the bimanual MICS technique. MICS significant development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision. This is not only a change in surgery technique, but it is a significant progress in safety and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and provides the opportunity for fast visual rehabilitation from the first week after cataract surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique fully meet the requirements of modern refractive intraocular surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiMICS 1.4 | – | Procedure: BiMICSGroup 1.4 - Patients operated with 1.4 mm BiMICS technique |
| BiMICS 1.8 | – | Procedure: BiMICSGroup 1.8 - Patients operated with 1.8 mm BiMICS technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- 1.Clinical diagnose of senile cataract.
Key exclusion criteria (5 listed)
- Eye trauma in anamnesis.
- Eye surgery in anamnesis.
- Corneal surgery in anamnesis.
- Corneal irregular astigmatism.
- Corneal ectasia.
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 |
|---|---|---|
| BiMICSBiaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens. | Procedure or surgery | BiMICS 1.4, BiMICS 1.8 |
Primary outcome
Visual acuity
Time frame: 3 months
Snellen charts, EDTRS charts
4 secondary outcomes
Keratometry
Time frame: 3 months
Surgically Induced Astigmatism, SIA
Time frame: 3 months
Higher Order Aberrations, HOAs
Time frame: 3 months
Corneal Incision thickness
Time frame: 3 nmonths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- MICS and Incise IOLLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. UCVA, BCVA, SIA, HOAs, Corneal Incision thickness
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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.
Paweł Klonowski, MD principal investigator
Eyemed Centrum Okulistyczne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Senile, run by Eyemed Centrum Okulistyczne at 1 site in Poland.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Visual acuity (time frame: 3 months). 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 4 Jan 2019.