Cataract SenileNCT05790993
Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
An observational study of Cataract Senile, run by AST Products, Inc. at 1 site in Spain.
Trial summary
Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Senile
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2022to 20 Jul 2022
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with bilateral cataract submitted to cataract surgery by phacoemulsification and implantation of Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system
Who may be able to join
- Patients 50 years or older submitted to cataract surgery and implanted with Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system.
- Patients submitted to bilateral cataract surgery.
- Transparent ocular media, other than the bilateral cataract.
Who cannot join
- Preoperatory corneal astigmatism greater than 0.75D
- Corneal surgery or trauma prior to cataract surgery Irregular cornea
- Choroidal hemorrhage
- Microftalmos Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
Show all 18Show fewer
- Concomitant ocular disease
- Not age-related cataract
- Severe optic nerve atrophy
- Diabetic retinopathy
- Proliferative diabetic retinopathy
- Amblyopia
- Extremelly shallow anterior chamber
- Severe chronic uveitis
- Rubella
- Mature/dense cataract difficulting fundas assessment preoperatively
- Prior retinal detachment
- Concurrent participation in another investigation with medication or clinical devices
Trial locations and contacts
1 site in 1 country.
About this study
Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. In order to allow cataract extraction and IOL insertion, during the surgery a small incision is performed by the surgeon. This incision is performed using surgical knives, and a smaller incisión is associated with less postoperatory inflammation, faster corneal wound healing, and faster visual recovery. Several studies reported the importance of smaller incisions to reduce the risk of surgically induced astigmatism.
In order to implant the IOL through this small incision, the IOL must be preloaded in a injector that allows introducing the IOL eficiently and consistently. The manual injector BIOLI manufactured by AST Products (model D), CE approved, is designed specifically to allow the IOL insertion safely, precisely, and controllably. Among the main characteristics of this delivery system is its design to minimize the incision size widening while inserting the IOL.
The present retrospective study aims to provide more information with regards to the clinical efficacy of the BIOLI-D delivery system for the implantation of the trifocal Asqelio TFLIO130C IOL in patients submitted to cataract surgery. This will be assessed by analyzing the change in incision size after IOL implantation and the incidence of adverse events during and after the procedure.
- Conditions
- Cataract Senile
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision size after incision
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Measured: Immediately after clear incision is performed
Incision size before IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Measured: Immediately after phacoemulsification is complete
Incision size after IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Measured: Immediately after IOL implantation
Adverse events
Incidence of adverse events related to the use of the device, coded according to the Medical Dictionary for Regulatory Activities, and analyzed per eye (ocular), and per subject (non ocular)
Measured: During or after the surgical procedure
Secondary outcomes (6)
Best corrected visual acuity
Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype
Measured: Before surgery
Best corrected visual acuity
Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype
Measured: One month after surgery
Refractive error PreOp
Manifest refraction before surgery in Diopters
Measured: Before surgery
Refractive error PostOp
Manifest refraction after surgery in Diopters
Measured: One month after surgery
Intraocular Pressure (IOP)
Preoperative intraocular pressure measured in mmHg
Measured: Before surgery
Cataract grading
Cataract grading before surgery using the LOCS III grading system
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start20 Jun 2022
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
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 only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790993
- Sponsor's protocol ID
- BIOLI012021
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
- ClinicalTrials.gov ID
- NCT05790993
- Acronym / sponsor ID
- BIOLI012021
- Conditions
- Cataract Senile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 30 Mar 2023 (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.
Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. In order to allow cataract extraction and IOL insertion, during the surgery a small incision is performed by the surgeon. This incision is performed using surgical knives, and a smaller incisión is associated with less postoperatory inflammation, faster corneal wound healing, and faster visual recovery. Several studies reported the importance of smaller incisions to reduce the risk of surgically induced astigmatism.
In order to implant the IOL through this small incision, the IOL must be preloaded in a injector that allows introducing the IOL eficiently and consistently. The manual injector BIOLI manufactured by AST Products (model D), CE approved, is designed specifically to allow the IOL insertion safely, precisely, and controllably. Among the main characteristics of this delivery system is its design to minimize the incision size widening while inserting the IOL.
The present retrospective study aims to provide more information with regards to the clinical efficacy of the BIOLI-D delivery system for the implantation of the trifocal Asqelio TFLIO130C IOL in patients submitted to cataract surgery. This will be assessed by analyzing the change in incision size after IOL implantation and the incidence of adverse events during and after the procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bilateral cataract submitted to cataract surgery by phacoemulsification and implantation of Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system
Key inclusion criteria (3 listed)
- Patients 50 years or older submitted to cataract surgery and implanted with Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system.
- Patients submitted to bilateral cataract surgery.
- Transparent ocular media, other than the bilateral cataract.
Key exclusion criteria (18 listed)
- Preoperatory corneal astigmatism greater than 0.75D
- Corneal surgery or trauma prior to cataract surgery Irregular cornea
- Choroidal hemorrhage
- Microftalmos Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incision size after incision
Time frame: Immediately after clear incision is performed
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size before IOL implantation
Time frame: Immediately after phacoemulsification is complete
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size after IOL implantation
Time frame: Immediately after IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Adverse events
Time frame: During or after the surgical procedure
Incidence of adverse events related to the use of the device, coded according to the Medical Dictionary for Regulatory Activities, and analyzed per eye (ocular), and per subject (non ocular)
6 secondary outcomes
Best corrected visual acuity
Time frame: Before surgery
Best corrected visual acuity
Time frame: One month after surgery
Refractive error PreOp
Time frame: Before surgery
Refractive error PostOp
Time frame: One month after surgery
Intraocular Pressure (IOP)
Time frame: Before surgery
Cataract grading
Time frame: Before surgery
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 30 Mar 2023.
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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.
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 AST Products, Inc. at 1 site in Spain.
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 3 inclusion and 18 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 30 Mar 2023. 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 Spain. 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?
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?
Incision size after incision (time frame: Immediately after clear incision is performed). The study lists 4 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 30 Mar 2023.