CataractPoyPODF/FTNCT04943809
Comparison of Visual Outcomes After Implantation of the POD FT and the POD F
An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Spain.
Trial summary
There is no difference of the photic phenomena in the two groups. The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- POD 26P AY FT and POD 26P AY F
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jul 2014to 20 Jul 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients undergoing routine cataract surgery. The study participants receive a bilateral implantation of trifocal intraocular lenses. Depending on the preoperative corneal astigmatism, the patients receive either non-toric trifocal IOLs (POD F) or toric trifocal IOLs (POD FT) in both eyes.
Who may be able to join
- Age-related cataract
- Preoperative Corneal astigmatism < 0.75 D
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- Patient willing multifocal implantation and with realistic expectations.
Who cannot join
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
- Previous ocular surgery or trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Visual Outcomes After Implantation of the POD 26P AY FT (PhysIOL) and the POD 26P AY F (PhysIOL)
There is no difference of the photic phenomena in the two groups.
The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.
Read the detailed description
The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.
We used the 'TrialSize' package of the R software. Here are the parameters defined for the sample size calculation:
- Alpha: 0.05
- Power : 0.90
- Two sided test
- Equal group allocation
- Standard deviation for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.10
- Expected mean for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.89 (true difference between the means equal 0)
- An equivalence limit of 0.05, 0.10 and 0.15 Equivalence limit: 0.15 In order to show no difference between these two groups, 12 patients by groups are needed. With a drop-out of 15%, we obtain 30 patients (15 patients by group) to recruit in order to obtain 24 valuable patients.
Equivalence limit: 0.10 In order to show no difference between these two groups, 26 patients by groups are needed. With a drop-out of 15%, we obtain 62 patients (31 patients by group) to recruit in order to obtain 52 valuable patients.
This total number of subjects with such requirement is 26 patients in each group.
Group 1 will be made of 26 patients with corneal astigmatism higher than 1.0D in both eyes and lower than 2.5D and will be implanted with the POD 26P AY FT and Group 2 will be made of 26 patients with corneal astigmatism lower than 1.0D in both eyes.
Interim analysis after the 12th patient of each group will have completed the last follow-up will be achieved to confirm the equivalence with the equivalence limit of 0.15.
The POD platform in 26 % (non toric version) is available since 2008 in the monofocal version and since 2012 in the toric one (POD 6P AY T, Ankoris®, PhysIOL).The so-called POD design is characterised by two symmetrical bifid haptics with opened loops that provide four points of support to ensure IOL stability in the capsular bag. The dual C-loop profile shortens the loops, thus improving the pliability of the implant during its injection through a micro-incision. These shortened loops should permit a clockwise or anticlockwise rotary motion and should facilitate the comfortable fitting of the implant orientation after unfolding without elastic-restoring torque. The double C-loop POD design offers 4 support points for the implant within the capsule and ensures its stability. The V-shape of the upper and lower haptics together with the flexibility of the implant allow the loop separation angle to be adjusted and ensure the most accurate adaptation to the capsular bag size. A finite element structural analysis of the implant showed that the elasticity at the distal part of the loop prevents the constraints from being transmitted onto the optical portion of the implant. The trifocal optic is associated to the POD platform and is made of 26 % raw material.
The rotational stability of this non toric version has been clinically investigated on 117 consecutive eyes 1 week, 3 weeks, 3 and 12 months after implantation. The absolute rotation of the lens averaged 2.5 ± 2.6°. The position of the center of the implant relative to the pupillary center expressed by a vector was 0.01 mm at 70°.
The investigational product (POD 26P AY FT) is CE labeled since January 2014. Main IOL features are:
- Biconvex toric aspheric (-0.11um SA) blue-blocking, hydrophilic acrylic IOL with 26% equlibrium water content, implantable through ≥ 2.2mm incision.
- 4-point haptic design
- 6 mm of optical diameter / 11.4 mm of total diameter
- Dioptric range (SE): 6 to 35 D by 0.5 D increments
- Cylinders at the IOL plane: 1, 1.5, 2.25, 3, 3.75, 4.5, 5.25, 6 D
- Addition +1.75D / +3.5 D
The control product (POD 26P AY F) is CE labeled since 2010. Main IOL features are:
- Biconvex, aspheric (-0.11um SA) blue-blocking, hydrophilic acrylic IOL with 26% equlibrium water content, implantable through ≥ 2.2mm incision.
- 4-point haptics design which minimizes decentration and optimizes the rotational stability
- 6 mm of optical diameter / 11.4 mm of total diameter
- Dioptric range (SE): 6 to 35 D by 0.5 D increments
- Addition +1.75D / +3.5 D
- Conditions
- Cataract
- Being tested
- POD 26P AY FT, POD 26P AY F
- Keywords
- Hydrophilic, Toric, intraocular lens, cataract, trifocal, BVI Medical
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POD 26P AY FTDevice
Routine cataract surgery
POD 26P AY FDevice
Routine cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| POD 26P AY FT | 26 patients with corneal astigmatism higher than 1.0D in both eyes and lower than 2.5D and will be implanted with the POD 26P AY FT Receives: Device: POD 26P AY FT | |
| POD 26P AY F | 26 patients with corneal astigmatism lower than 1.0D in both eyes will be implanted with the POD 26P AY F Receives: Device: POD 26P AY F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the equivalence of the glare
The primary endpoint is to show statistically equivalent outcomes on glare at the 3 months follow up visit. A significance level of p = 0.05 will be considered statistically significant.
Measured: 3 Months
Secondary outcomes (6)
Measurement of far, intermediate and near visual acuity
The secondary objective is to measure far, intermediate and near visual acuity of the POD AY 26P FT with respect to the POD AY 26P F.
Measured: 6 Months
Refraction
The secondary objective is to measure the refraction of the POD AY 26P FT with respect to the POD AY 26P F.
Measured: 6 Months
Centration
The secondary objective is to measure the centration of the POD AY 26P FT with respect to the POD AY 26P F.
Measured: 6 Months
Rotational stability
The secondary objective is to measure the rotational stability of the POD AY 26P FT with respect to the POD AY 26P F.
Measured: 6 Months
Equivalence of the visual acuity and the contrast sensitivity
The secondary objective is to determine the equivalence of the visual acuity of the POD AY 26P FT with respect to the POD AY 26P F.
Measured: 6 Months
Equivalence of the visual acuity and the contrast sensitivity
The secondary objective is to determine the contrast sensitivity at far of the POD AY 26P FT with respect to the POD AY 26P F.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start16 Jul 2014
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Poyales Galan, PhD, Principal investigator, CEIC Hospital Clinical San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943809
- Sponsor's protocol ID
- Poyales/POD FT - POD F
- Acronym
- PoyPODF/FT
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chassain C, Pagnoulle C, Gobin L, Rozema J. [Evaluation of a new intraocular lens platform: centration and rotational stability]. J Fr Ophtalmol. 2013 Apr;36(4):336-42. doi: 10.1016/j.jfo.2012.04.012. Epub 2013 Jan 24. French.
PubMed 23352708Visser N, Bauer NJ, Nuijts RM. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications. J Cataract Refract Surg. 2013 Apr;39(4):624-37. doi: 10.1016/j.jcrs.2013.02.020.
PubMed 23522584de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.
PubMed 23332253Wolffsohn JS, Jinabhai AN, Kingsnorth A, Sheppard AL, Naroo SA, Shah S, Buckhurst P, Hall LA, Young G. Exploring the optimum step size for defocus curves. J Cataract Refract Surg. 2013 Jun;39(6):873-80. doi: 10.1016/j.jcrs.2013.01.031.
PubMed 23688874Sheppard AL, Shah S, Bhatt U, Bhogal G, Wolffsohn JS. Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens. J Cataract Refract Surg. 2013 Mar;39(3):343-9. doi: 10.1016/j.jcrs.2012.09.017. Epub 2013 Jan 16.
PubMed 23332118Cochener B, Vryghem J, Rozot P, Lesieur G, Heireman S, Blanckaert JA, Van Acker E, Ghekiere S. Visual and refractive outcomes after implantation of a fully diffractive trifocal lens. Clin Ophthalmol. 2012;6:1421-7. doi: 10.2147/OPTH.S32343. Epub 2012 Sep 3.
PubMed 22969289Roensch MA, Charton JW, Blomquist PH, Aggarwal NK, McCulley JP. Resident experience with toric and multifocal intraocular lenses in a public county hospital system. J Cataract Refract Surg. 2012 May;38(5):793-8. doi: 10.1016/j.jcrs.2011.11.043. Epub 2012 Mar 15.
PubMed 22425363Visser N, Nuijts RM, de Vries NE, Bauer NJ. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg. 2011 Nov;37(11):2034-42. doi: 10.1016/j.jcrs.2011.05.041. Epub 2011 Sep 22.
PubMed 21940140Bellucci R, Bauer NJ, Daya SM, Visser N, Santin G, Cargnoni M, Nuijts RM; Lisa Toric Study Group. Visual acuity and refraction with a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 2013 Oct;39(10):1507-18. doi: 10.1016/j.jcrs.2013.04.036.
PubMed 24075158Alfonso JF, Knorz M, Fernandez-Vega L, Rincon JL, Suarez E, Titke C, Kohnen T. Clinical outcomes after bilateral implantation of an apodized +3.0 D toric diffractive multifocal intraocular lens. J Cataract Refract Surg. 2014 Jan;40(1):51-9. doi: 10.1016/j.jcrs.2013.06.026.
PubMed 24355720Ferreira TB, Marques EF, Rodrigues A, Montes-Mico R. Visual and optical outcomes of a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 2013 Jul;39(7):1029-35. doi: 10.1016/j.jcrs.2013.02.037. Epub 2013 May 13.
PubMed 23680631Knorz MC, Rincon JL, Suarez E, Alfonso JF, Fernandez-Vega L, Titke C, Kohnen T, Tucker S. Subjective outcomes after bilateral implantation of an apodized diffractive +3.0 D multifocal toric IOL in a prospective clinical study. J Refract Surg. 2013 Nov;29(11):762-7. doi: 10.3928/1081597X-20131021-06.
PubMed 24203808
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes After Implantation of the POD 26P AY FT (PhysIOL) and the POD 26P AY F (PhysIOL)
- ClinicalTrials.gov ID
- NCT04943809
- Acronym / sponsor ID
- PoyPODF/FT / Poyales/POD FT - POD F
- Conditions
- Cataract
- Keywords
- Hydrophilic, Toric, intraocular lens, cataract, trifocal, BVI Medical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 29 Jun 2021 (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.
There is no difference of the photic phenomena in the two groups.
The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.
Detailed description
The study will be a prospective non-randomised controlled study. The target is then to determine the equivalence in the glare. Assumption of Type I error is p=0.05 as level of significance and Type II error is alpha=0.8 as power.
We used the 'TrialSize' package of the R software. Here are the parameters defined for the sample size calculation:
- Alpha: 0.05
- Power : 0.90
- Two sided test
- Equal group allocation
- Standard deviation for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.10
- Expected mean for the two groups (POD 26P AY F et POD 26P AY FT) equal to 0.89 (true difference between the means equal 0)
- An equivalence limit of 0.05, 0.10 and 0.15 Equivalence limit: 0.15 In order to show no difference between these two groups, 12 patients by groups are needed. With a drop-out of 15%, we obtain 30 patients (15 patients by group) to recruit in order to obtain 24 valuable patients.
Equivalence limit: 0.10 In order to show no difference between these two groups, 26 patients by groups are needed. With a drop-out of 15%, we obtain 62 patients (31 patients by group) to recruit in order to obtain 52 valuable patients.
This total number of subjects with such requirement is 26 patients in each group.
Group 1 will be made of 26 patients with corneal astigmatism higher than 1.0D in both eyes and lower than 2.5D and will be implanted with the POD 26P AY FT and Group 2 will be made of 26 patients with corneal astigmatism lower than 1.0D in both eyes.
Interim analysis after the 12th patient of each group will have completed the last follow-up will be achieved to confirm the equivalence with the equivalence limit of 0.15.
The POD platform in 26 % (non toric version) is available since 2008 in the monofocal version and since 2012 in the toric one (POD 6P AY T, Ankoris®, PhysIOL).The so-called POD design is characterised by two symmetrical bifid haptics with opened loops that provide four points of support to ensure IOL stability in the capsular bag. The dual C-loop profile shortens the loops, thus improving the pliability of the implant during its injection through a micro-incision. These shortened loops should permit a clockwise or anticlockwise rotary motion and should facilitate the comfortable fitting of the implant orientation after unfolding without elastic-restoring torque. The double C-loop POD design offers 4 support points for the implant within the capsule and ensures its stability. The V-shape of the upper and lower haptics together with the flexibility of the implant allow the loop separation angle to be adjusted and ensure the most accurate adaptation to the capsular bag size. A finite element structural analysis of the implant showed that the elasticity at the distal part of the loop prevents the constraints from being transmitted onto the optical portion of the implant. The trifocal optic is associated to the POD platform and is made of 26 % raw material.
The rotational stability of this non toric version has been clinically investigated on 117 consecutive eyes 1 week, 3 weeks, 3 and 12 months after implantation. The absolute rotation of the lens averaged 2.5 ± 2.6°. The position of the center of the implant relative to the pupillary center expressed by a vector was 0.01 mm at 70°.
The investigational product (POD 26P AY FT) is CE labeled since January 2014. Main IOL features are:
- Biconvex toric aspheric (-0.11um SA) blue-blocking, hydrophilic acrylic IOL with 26% equlibrium water content, implantable through ≥ 2.2mm incision.
- 4-point haptic design
- 6 mm of optical diameter / 11.4 mm of total diameter
- Dioptric range (SE): 6 to 35 D by 0.5 D increments
- Cylinders at the IOL plane: 1, 1.5, 2.25, 3, 3.75, 4.5, 5.25, 6 D
- Addition +1.75D / +3.5 D
The control product (POD 26P AY F) is CE labeled since 2010. Main IOL features are:
- Biconvex, aspheric (-0.11um SA) blue-blocking, hydrophilic acrylic IOL with 26% equlibrium water content, implantable through ≥ 2.2mm incision.
- 4-point haptics design which minimizes decentration and optimizes the rotational stability
- 6 mm of optical diameter / 11.4 mm of total diameter
- Dioptric range (SE): 6 to 35 D by 0.5 D increments
- Addition +1.75D / +3.5 D
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD 26P AY FT | – | Device: POD 26P AY FT26 patients with corneal astigmatism higher than 1.0D in both eyes and lower than 2.5D and will be implanted with the POD 26P AY FT |
| POD 26P AY F | – | Device: POD 26P AY F26 patients with corneal astigmatism lower than 1.0D in both eyes will be implanted with the POD 26P AY F |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients undergoing routine cataract surgery. The study participants receive a bilateral implantation of trifocal intraocular lenses. Depending on the preoperative corneal astigmatism, the patients receive either non-toric trifocal IOLs (POD F) or toric trifocal IOLs (POD FT) in both eyes.
Key inclusion criteria (6 listed)
- Age-related cataract
- Preoperative Corneal astigmatism < 0.75 D
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Key exclusion criteria (2 listed)
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
- Previous ocular surgery or trauma.
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 |
|---|---|---|
| POD 26P AY FTRoutine cataract surgery | Device | POD 26P AY FT |
| POD 26P AY FRoutine cataract surgery | Device | POD 26P AY F |
Primary outcome
Determine the equivalence of the glare
Time frame: 3 Months
The primary endpoint is to show statistically equivalent outcomes on glare at the 3 months follow up visit. A significance level of p = 0.05 will be considered statistically significant.
6 secondary outcomes
Measurement of far, intermediate and near visual acuity
Time frame: 6 Months
Refraction
Time frame: 6 Months
Centration
Time frame: 6 Months
Rotational stability
Time frame: 6 Months
Equivalence of the visual acuity and the contrast sensitivity
Time frame: 6 Months
Equivalence of the visual acuity and the contrast sensitivity
Time frame: 6 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 1 Jul 2021.
- Background: PubMed 23352708Chassain C, Pagnoulle C, Gobin L, Rozema J. [Evaluation of a new intraocular lens platform: centration and rotational stability]. J Fr Ophtalmol. 2013 Apr;36(4):336-42. doi: 10.1016/j.jfo.2012.04.012. Epub 2013 Jan 24. French.
- Results publication: PubMed 23522584Visser N, Bauer NJ, Nuijts RM. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications. J Cataract Refract Surg. 2013 Apr;39(4):624-37. doi: 10.1016/j.jcrs.2013.02.020.
- Results publication: PubMed 23332253de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.
- Results publication: PubMed 23688874Wolffsohn JS, Jinabhai AN, Kingsnorth A, Sheppard AL, Naroo SA, Shah S, Buckhurst P, Hall LA, Young G. Exploring the optimum step size for defocus curves. J Cataract Refract Surg. 2013 Jun;39(6):873-80. doi: 10.1016/j.jcrs.2013.01.031.
- Results publication: PubMed 23332118Sheppard AL, Shah S, Bhatt U, Bhogal G, Wolffsohn JS. Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens. J Cataract Refract Surg. 2013 Mar;39(3):343-9. doi: 10.1016/j.jcrs.2012.09.017. Epub 2013 Jan 16.
- Results publication: PubMed 22969289Cochener B, Vryghem J, Rozot P, Lesieur G, Heireman S, Blanckaert JA, Van Acker E, Ghekiere S. Visual and refractive outcomes after implantation of a fully diffractive trifocal lens. Clin Ophthalmol. 2012;6:1421-7. doi: 10.2147/OPTH.S32343. Epub 2012 Sep 3.
- Results publication: PubMed 22425363Roensch MA, Charton JW, Blomquist PH, Aggarwal NK, McCulley JP. Resident experience with toric and multifocal intraocular lenses in a public county hospital system. J Cataract Refract Surg. 2012 May;38(5):793-8. doi: 10.1016/j.jcrs.2011.11.043. Epub 2012 Mar 15.
- Results publication: PubMed 21940140Visser N, Nuijts RM, de Vries NE, Bauer NJ. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg. 2011 Nov;37(11):2034-42. doi: 10.1016/j.jcrs.2011.05.041. Epub 2011 Sep 22.
- Results publication: PubMed 24075158Bellucci R, Bauer NJ, Daya SM, Visser N, Santin G, Cargnoni M, Nuijts RM; Lisa Toric Study Group. Visual acuity and refraction with a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 2013 Oct;39(10):1507-18. doi: 10.1016/j.jcrs.2013.04.036.
- Results publication: PubMed 24355720Alfonso JF, Knorz M, Fernandez-Vega L, Rincon JL, Suarez E, Titke C, Kohnen T. Clinical outcomes after bilateral implantation of an apodized +3.0 D toric diffractive multifocal intraocular lens. J Cataract Refract Surg. 2014 Jan;40(1):51-9. doi: 10.1016/j.jcrs.2013.06.026.
- Results publication: PubMed 23680631Ferreira TB, Marques EF, Rodrigues A, Montes-Mico R. Visual and optical outcomes of a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 2013 Jul;39(7):1029-35. doi: 10.1016/j.jcrs.2013.02.037. Epub 2013 May 13.
- Results publication: PubMed 24203808Knorz MC, Rincon JL, Suarez E, Alfonso JF, Fernandez-Vega L, Titke C, Kohnen T, Tucker S. Subjective outcomes after bilateral implantation of an apodized diffractive +3.0 D multifocal toric IOL in a prospective clinical study. J Refract Surg. 2013 Nov;29(11):762-7. doi: 10.3928/1081597X-20131021-06.
- 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.
Francisco Poyales Galan, PhD principal investigator
CEIC Hospital Clinical San Carlos
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, run by Beaver-Visitec International, 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 6 inclusion and 2 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 1 Jul 2021. 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?
Determine the equivalence of the glare (time frame: 3 Months). 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 NCT04943809, which also lists 12 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 1 Jul 2021.