Cataract SenilePEACENCT02970487
Precisight® Intraocular Lens Implantation for Cataract Treatment
A study testing Intraocular implant of the Precisight in people with Cataract Senile, run by InfiniteVision Optics at 1 site in Philippines.
Trial summary
The purpose of this study is to determine the refractive outcomes and optimize the clinical features of a new intraocular lens intended to treat the senile cataract. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Intraocular implant of the Precisight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePhilippines
- Study dates
- Jun 2016to Jul 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related bilateral cataract or one pseudophakic eye
- Visual acuity potential of the study eye of at least 0.63 (decimal)
- Expected postoperative astigmatism of ≤0.75 D in the study eye
- IOL power within available diopters
- Written informed patient consent regarding participation in the study and data protection
Who cannot join
- Visually significant corneal scars
- Ocular disorders - other than cataract - that could potentially cause future acuity losses to a level of 0.5 (decimal) or worse in the study eye
- Relevant concomitant ophthalmic diseases (such as pseudoexfoliation, angleclosure glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
- Participation of patient in other clinical trials (former participation is not an exclusion criterion)
- Any cataract condition that makes the assessment of retina status difficult
- Anyone with unstable systemic conditions or untreated systemic medical problems including but not limited to the following: Untreated diabetes, Cardiovascular untreated disease, Pulmonary untreated disease, Any untreated infection, Neuro-ophthalmologic diseases, Any allergy to the medications used during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refractive Outcome and Optimization of IOL-Constants After Implantation of the Precisight® Intraocular Lens.
The purpose of this study is to determine the refractive outcomes and optimize the clinical features of a new intraocular lens intended to treat the senile cataract.
Read the detailed description
InfiniteVision Optics has developed a new IOL system, the Precisight IOL. This IOL consists of a combination of two lenses: a base lens which is placed permanently into the capsular bag, and a front lens which sits on top of the base lens outside the capsular bag. The major advantage of this system is the adjustability of the primary IOL implantation which is done by front lens exchange. In case of either postoperative refractive adjustments or patient dissatisfaction with the visual performance, the front lens can be easily exchange by a less invasive surgery, avoiding a total IOL explantation. The implantation of the Precisight IOL is similar to the implantation of a traditional intraocular lens with no expected additional risk.
For all new IOLs, the IOL-constants are determined and provided by the manufacturer. They are calculated on the basis of eye models and clinical testing. In this study the biometric data of each patient's eye will be documented together with the implanted lens power and the postoperative stable refraction for calculation of the optimized IOL-constants.
In the present study, 125 subjects will be enrolled. Patients with a deviation from target refraction of more than 0.5 D spherical equivalent at the 2-3 month follow-up visit will undergo a secondary intervention for exchange of the front lens. These patients will be followed up for 1 year after front lens exchange.
Subjects will be screened during a pre-operative visit. Before the surgery visit, the subjected must have signed the Informed Consent Form.
After the surgery, patients will be followed up for one year. The visits will be scheduled at 1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after surgery. Patients who underwent a surgery to exchange the front lens will be also followed up 1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after the exchange surgery.
Investigator site staff will document the data in electronic Case Report Forms (eCRF). The data will be pseudonymized, i.e. only the year of birth and a code will be entered in the eCRF. Adverse events will be recorded in an eCRFs. Unexpected and serious adverse events are to be reported to the manufacturer.
Data cleaning will be done one month after last patient out and study report finished three months after last patient out. Subjects must be withdrawn from the study (i) at their own request, (ii) in case of intraoperative complication impacting the safety of the patient or (iii) in case of any postoperative complication if the continuation of the study has an impact on the safety of the patient. The study may terminate before completion if a high relative number of individual subject withdrawals due to the patient's requests and/or clinically relevant complications are observed. The IRB will be informed in due course accordingly.
The findings of this study will be published by the investigators in a scientific journal and presented at scientific meetings.
- Conditions
- Cataract Senile
- Being tested
- Intraocular implant of the Precisight
- Keywords
- cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular implant of the PrecisightDevice
Precisight ismplanted in place of the natural cloudy lens, inside the capsular bag.
| Study group | Role | What they receive |
|---|---|---|
| investigational device | Experimental | Subjects implanted with the Precisight intraocular lens. Receives: Device: Intraocular implant of the Precisight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the subjective refraction
The evolution of subjective refraction will be assessed after Precisight implantation.
Measured: 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Secondary outcomes (5)
Best-corrected distance visual acuity
Measured: 1 day, 7 to 14 days, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Introcular lens (IOL) decentration and tilt
Measured: day of surgery, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Anterior chamber depth
Measured: pre-operative, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Adverse events
Measured: All follow up period (1 year)
Assessment of investigator regarding handling and achievement of target refraction
The investigator shall answer a questionnaire.
Measured: Six months after investigational device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020 (estimated)
- Study completionJul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- InfiniteVision Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Targomed
- Responsible party
- Sponsor
- Investigators
- Harvey S Uy, MD, Principal investigator, Peregrine Eye and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970487
- Sponsor's protocol ID
- 2015-0023
- Acronym
- PEACE
- Status last verified
- Feb 2019
- First submitted
- 10 Nov 2016
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Outcome and Optimization of IOL-Constants After Implantation of the Precisight® Intraocular Lens.
- ClinicalTrials.gov ID
- NCT02970487
- Acronym / sponsor ID
- PEACE / 2015-0023
- Conditions
- Cataract Senile
- Keywords
- cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- InfiniteVision OpticsIndustry (pharma, biotech, devices)
- Collaborators
- Targomed
- Study start
- Jun 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- 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 purpose of this study is to determine the refractive outcomes and optimize the clinical features of a new intraocular lens intended to treat the senile cataract.
Detailed description
InfiniteVision Optics has developed a new IOL system, the Precisight IOL. This IOL consists of a combination of two lenses: a base lens which is placed permanently into the capsular bag, and a front lens which sits on top of the base lens outside the capsular bag. The major advantage of this system is the adjustability of the primary IOL implantation which is done by front lens exchange. In case of either postoperative refractive adjustments or patient dissatisfaction with the visual performance, the front lens can be easily exchange by a less invasive surgery, avoiding a total IOL explantation. The implantation of the Precisight IOL is similar to the implantation of a traditional intraocular lens with no expected additional risk.
For all new IOLs, the IOL-constants are determined and provided by the manufacturer. They are calculated on the basis of eye models and clinical testing. In this study the biometric data of each patient's eye will be documented together with the implanted lens power and the postoperative stable refraction for calculation of the optimized IOL-constants.
In the present study, 125 subjects will be enrolled. Patients with a deviation from target refraction of more than 0.5 D spherical equivalent at the 2-3 month follow-up visit will undergo a secondary intervention for exchange of the front lens. These patients will be followed up for 1 year after front lens exchange.
Subjects will be screened during a pre-operative visit. Before the surgery visit, the subjected must have signed the Informed Consent Form.
After the surgery, patients will be followed up for one year. The visits will be scheduled at 1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after surgery. Patients who underwent a surgery to exchange the front lens will be also followed up 1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after the exchange surgery.
Investigator site staff will document the data in electronic Case Report Forms (eCRF). The data will be pseudonymized, i.e. only the year of birth and a code will be entered in the eCRF. Adverse events will be recorded in an eCRFs. Unexpected and serious adverse events are to be reported to the manufacturer.
Data cleaning will be done one month after last patient out and study report finished three months after last patient out. Subjects must be withdrawn from the study (i) at their own request, (ii) in case of intraoperative complication impacting the safety of the patient or (iii) in case of any postoperative complication if the continuation of the study has an impact on the safety of the patient. The study may terminate before completion if a high relative number of individual subject withdrawals due to the patient's requests and/or clinically relevant complications are observed. The IRB will be informed in due course accordingly.
The findings of this study will be published by the investigators in a scientific journal and presented at scientific meetings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| investigational device | Experimental | Device: Intraocular implant of the PrecisightSubjects implanted with the Precisight intraocular lens. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age-related bilateral cataract or one pseudophakic eye
- Visual acuity potential of the study eye of at least 0.63 (decimal)
- Expected postoperative astigmatism of ≤0.75 D in the study eye
- IOL power within available diopters
- Written informed patient consent regarding participation in the study and data protection
Key exclusion criteria (6 listed)
- Visually significant corneal scars
- Ocular disorders - other than cataract - that could potentially cause future acuity losses to a level of 0.5 (decimal) or worse in the study eye
- Relevant concomitant ophthalmic diseases (such as pseudoexfoliation, angleclosure glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
- Participation of patient in other clinical trials (former participation is not an exclusion criterion)
- Any cataract condition that makes the assessment of retina status difficult
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 |
|---|---|---|
| Intraocular implant of the PrecisightPrecisight ismplanted in place of the natural cloudy lens, inside the capsular bag. | Device | investigational device |
Primary outcome
Change of the subjective refraction
Time frame: 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
The evolution of subjective refraction will be assessed after Precisight implantation.
5 secondary outcomes
Best-corrected distance visual acuity
Time frame: 1 day, 7 to 14 days, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Introcular lens (IOL) decentration and tilt
Time frame: day of surgery, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Anterior chamber depth
Time frame: pre-operative, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
Adverse events
Time frame: All follow up period (1 year)
Assessment of investigator regarding handling and achievement of target refraction
Time frame: Six months after investigational device implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Harvey S Uy, MD principal investigator
Peregrine Eye and Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular implant of the Precisight in people with Cataract Senile, run by InfiniteVision Optics at 1 site in Philippines.
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 5 inclusion and 6 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 1 Mar 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 Philippines. 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?
Change of the subjective refraction (time frame: 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation). 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 1 Mar 2019.