CataractPSM15NCT02838004
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
A study testing IOL MINI WELL READY in people with Cataract and Presbyopia, run by SIFI SpA at 1 site in Germany.
Trial summary
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- IOL MINI WELL READY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender and age above 18 years.
- Refractive lens exchange (RLE) or cataract surgery.
- Healthy corneas, not treated surgically.
- Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
- Patients request to receive the IOL MINI WELL READY implant
Who cannot join
- Previous corneal surgery (i.e. pterygium, refractive surgery).
- Eye diseases determining a probable postoperative visual acuity < 20/40.
- Pseudoexfoliation.
- Abnormal pupil size and position.
- Use of contact lens 30 days before the preoperative visit.
- Corneal warpage.
- Predicted postoperative corneal astigmatism higher than 1 D.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
Read the detailed description
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
- Conditions
- Cataract, Presbyopia
- Being tested
- IOL MINI WELL READY
- Keywords
- Refractive lens exchange (RLE) or cataract surgery
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL MINI WELL READYDevice
IOL MINI WELL READY
| Study group | Role | What they receive |
|---|---|---|
| Single arm receiving Mini WELL Ready IOL | Experimental | IOL implantation for cataract Receives: Device: IOL MINI WELL READY |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDVA (Uncorrected Distance Visual Acuity)
Visual acuity mesurement
Measured: 30 days
Secondary outcomes (1)
Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).
Safety assessment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- GERD U. AUFFARTH, Prof. Dr., Principal investigator, RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838004
- Sponsor's protocol ID
- PSM15
- Acronym
- PSM15
- Status last verified
- Jan 2020
- First submitted
- 12 Jul 2016
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jiang T, Jiang J, Zhou Y, Zhao GQ, Li H, Zhao SY. Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. Int J Ophthalmol. 2011;4(5):513-8. doi: 10.3980/j.issn.2222-3959.2011.05.11. Epub 2011 Oct 18.
PubMed 22553713Packer M, Fine IH, Hoffman RS. Aspheric intraocular lens selection: the evolution of refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):1-4. doi: 10.1097/ICU.0b013e3282f2d791. No abstract available.
PubMed 18090888Kohnen T, Klaproth OK, Buhren J. Effect of intraocular lens asphericity on quality of vision after cataract removal: an intraindividual comparison. Ophthalmology. 2009 Sep;116(9):1697-706. doi: 10.1016/j.ophtha.2009.03.052. Epub 2009 Jul 29.
PubMed 19643497Lehmann R, Waycaster C, Hileman K. A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039.
PubMed 17166341Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. doi: 10.1016/S0161-6420(03)00722-X.
PubMed 13129879Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.
PubMed 10724823Munoz G, Albarran-Diego C, Ferrer-Blasco T, Sakla HF, Garcia-Lazaro S. Visual function after bilateral implantation of a new zonal refractive aspheric multifocal intraocular lens. J Cataract Refract Surg. 2011 Nov;37(11):2043-52. doi: 10.1016/j.jcrs.2011.05.045.
PubMed 22018366Ucakhan OO, Ozkan M, Kanpolat A. Anterior chamber parameters measured by the Pentacam CES after uneventful phacoemulsification in normotensive eyes. Acta Ophthalmol. 2009 Aug;87(5):544-8. doi: 10.1111/j.1755-3768.2008.01305.x. Epub 2008 Sep 11.
PubMed 18786130Savini G, Olsen T, Carbonara C, Pazzaglia S, Barboni P, Carbonelli M, Hoffer KJ. Anterior chamber depth measurement in pseudophakic eyes: a comparison of Pentacam and ultrasound. J Refract Surg. 2010 May;26(5):341-7. doi: 10.3928/1081597X-20090617-02. Epub 2010 May 19.
PubMed 20506991Attia MS, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP. Near and intermediate visual and reading performance of patients with a multifocal apodized diffractive intraocular lens using an electronic reading desk. J Cataract Refract Surg. 2016 Apr;42(4):582-90. doi: 10.1016/j.jcrs.2015.11.047.
PubMed 27113882Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study. J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041.
PubMed 19969208
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
- ClinicalTrials.gov ID
- NCT02838004
- Acronym / sponsor ID
- PSM15 / PSM15
- Conditions
- Cataract, Presbyopia
- Keywords
- Refractive lens exchange (RLE) or cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Jul 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.
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
Detailed description
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm receiving Mini WELL Ready IOL | Experimental | Device: IOL MINI WELL READYIOL implantation for cataract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any gender and age above 18 years.
- Refractive lens exchange (RLE) or cataract surgery.
- Healthy corneas, not treated surgically.
- Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
- Patients request to receive the IOL MINI WELL READY implant
Key exclusion criteria (7 listed)
- Previous corneal surgery (i.e. pterygium, refractive surgery).
- Eye diseases determining a probable postoperative visual acuity < 20/40.
- Pseudoexfoliation.
- Abnormal pupil size and position.
- Use of contact lens 30 days before the preoperative visit.
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 |
|---|---|---|
| IOL MINI WELL READYIOL MINI WELL READY | Device | Single arm receiving Mini WELL Ready IOL |
Primary outcome
UDVA (Uncorrected Distance Visual Acuity)
Time frame: 30 days
Visual acuity mesurement
1 secondary outcome
Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).
Time frame: 4 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 14 Jan 2020.
- Background: PubMed 22553713Jiang T, Jiang J, Zhou Y, Zhao GQ, Li H, Zhao SY. Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. Int J Ophthalmol. 2011;4(5):513-8. doi: 10.3980/j.issn.2222-3959.2011.05.11. Epub 2011 Oct 18.
- Background: PubMed 18090888Packer M, Fine IH, Hoffman RS. Aspheric intraocular lens selection: the evolution of refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):1-4. doi: 10.1097/ICU.0b013e3282f2d791. No abstract available.
- Background: PubMed 19643497Kohnen T, Klaproth OK, Buhren J. Effect of intraocular lens asphericity on quality of vision after cataract removal: an intraindividual comparison. Ophthalmology. 2009 Sep;116(9):1697-706. doi: 10.1016/j.ophtha.2009.03.052. Epub 2009 Jul 29.
- Background: PubMed 17166341Lehmann R, Waycaster C, Hileman K. A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039.
- Background: PubMed 13129879Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. doi: 10.1016/S0161-6420(03)00722-X.
- Background: PubMed 10724823Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.
- Background: PubMed 22018366Munoz G, Albarran-Diego C, Ferrer-Blasco T, Sakla HF, Garcia-Lazaro S. Visual function after bilateral implantation of a new zonal refractive aspheric multifocal intraocular lens. J Cataract Refract Surg. 2011 Nov;37(11):2043-52. doi: 10.1016/j.jcrs.2011.05.045.
- Background: PubMed 18786130Ucakhan OO, Ozkan M, Kanpolat A. Anterior chamber parameters measured by the Pentacam CES after uneventful phacoemulsification in normotensive eyes. Acta Ophthalmol. 2009 Aug;87(5):544-8. doi: 10.1111/j.1755-3768.2008.01305.x. Epub 2008 Sep 11.
- Background: PubMed 20506991Savini G, Olsen T, Carbonara C, Pazzaglia S, Barboni P, Carbonelli M, Hoffer KJ. Anterior chamber depth measurement in pseudophakic eyes: a comparison of Pentacam and ultrasound. J Refract Surg. 2010 May;26(5):341-7. doi: 10.3928/1081597X-20090617-02. Epub 2010 May 19.
- Background: PubMed 27113882Attia MS, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP. Near and intermediate visual and reading performance of patients with a multifocal apodized diffractive intraocular lens using an electronic reading desk. J Cataract Refract Surg. 2016 Apr;42(4):582-90. doi: 10.1016/j.jcrs.2015.11.047.
- Background: PubMed 19969208Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study. J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041.
- 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.
GERD U. AUFFARTH, Prof. Dr. principal investigator
RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL MINI WELL READY in people with Cataract and Presbyopia, run by SIFI SpA at 1 site in Germany.
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 7 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 14 Jan 2020. 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 Germany. 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?
UDVA (Uncorrected Distance Visual Acuity) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838004, which also lists 11 linked publications.
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 14 Jan 2020.