An interventional study of POD L GF IOL and Symfony® IOL in Aphakia, Postcataract and Cataract; Eye Disease, sponsored by Beaver-Visitec International, Inc.. Completed at 5 sites in 3 countries. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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Among 36 studies in Cataract by Beaver-Visitec International, Inc. — none open to participants now, 2 under way, none of them phase 3. Cataract · Beaver-Visitec International, Inc..
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., this one is the 7th largest by enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2019, is one of 28 with no phase, and was the 15th registered.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →None of the 36 studies in Cataract by Beaver-Visitec International, Inc. is open now. The open studies under Cataract, anywhere →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2019.
This study's enrollment of 100 is above the median of 79 across 1,094 interventional studies indexed under Cataract.
Median enrollment 53 across the 28 interventional studies, 62 across the 8 observational. Of the 32 that completed or were terminated, 2 (6%) have results posted.
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Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objectives of the Post-Market Follow-up (PMCF) clinical investigation are to determine the safety and performance of a hydrophobic trifocal intraocular lens POD L GF in comparison with two comparator lenses: another multifocal intraocular lens (Johnson \& Johnson TECNIS Symfony® Extended Range of Vision IOL); and a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.
This is a prospective, multicenter, randomized, active controlled comparative binocular Post Market Follow-up (PMCF) clinical study to demonstrate safety and efficacy between the trifocal intraocular lens POD L GF and the Johnson \& Johnson TECNIS Symfony® Extended Range of Vision IOL and the Alcon AcrySof® IQ Monofocal IOL.
Patients who are scheduled to undergo cataract extraction in one or both eyes and posterior chamber intraocular lens implants may be screened for eligibility in the study and, if eligible, complete a pre-operative screening visit. Both eyes of subjects who are eligible to receive the POD L GF IOL or the Johnson \& Johnson TECNIS Symfony® Extended Range of Vision IOL must be eligible to receive bilateral multifocal IOL implants. Both eyes of subjects who are eligible to receive the Alcon AcrySof® IQ Monofocal IOL must be eligible to receive bilateral monofocal IOL implants.
At the time of the first eye surgery, the subjects to be implanted with either the POD L GF (test) IOL or the Johnson \& Johnson TECNIS Symfony® Extended Range of Vision (comparator) IOL will be randomized to receive either the test or comparator IOL in a 1:1 ratio. In addition, 50 subjects will be implanted with the Alcon AcrySof® IQ Monofocal IOL. All subjects will undergo bilateral IOL implantation and will receive the same brand of lenses in each eye. Second eye implantations will be delayed until 1 to 30 days after the first eye implantation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 50 subjects who are scheduled for multifocal IOL implantation and enrolled in the study will be randomized into the POD L GF arm. Subjects will be implanted bilaterally with the European Conformity (CE) marked POD L GF trifocal IOL and assessed according to the study visit schedule.
Device: POD L GF IOL
Approximately 50 subjects who are scheduled for multifocal IOL implantation and enrolled in the study will be randomized into the Symfony arm. Subjects will be implanted bilaterally with the CE marked TECNIS Symfony® IOL and assessed according to the study visit schedule.
Device: Symfony® IOL
Approximately 50 subjects who are scheduled for monofocal IOL implantation and enrolled in the study will be placed in the AcrySof® arm. Subjects will be implanted bilaterally with the CE marked AcrySof® IQ monofocal IOL and assessed according to the study visit schedule.
Device: AcrySof® IOL
Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag
Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag
Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag
CDVA in first implanted eyes
Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4
Time frame: Day 120-180 both eyes
DCIVA in first implanted eyes
Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA) in first implanted eyes at Visit 4
Time frame: Day 120-180 both eyes
DCNVA in first implanted eyes
Photopic monocular logMAR near visual acuity with distance correction (DCNVA) in first implanted eyes at Visit 4
Time frame: Day 120-180 both eyes
UDVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR uncorrected distance visual acuity (UDVA)
Time frame: Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
UIVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR uncorrected intermediate visual acuity (UIVA)
Time frame: Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
UNVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR uncorrected near visual acuity (UNVA)
Time frame: Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
CDVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR corrected distance visual acuity (CDVA)
Time frame: Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
DCIVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA)
Time frame: Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
DCNVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR corrected near visual acuity with distance correction (DCNVA)
Time frame: Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
Quality of Vision Questionnaire (QoV) quality of vision at Visit 4
Quality of vision based on response to each question in the Quality of Vision (QoV) questionnaire at Visit 4. Answer is a choice of 4 options, the first being the least and the fourth being the most based on question type, i.e. "never" to "very often" or "not at all" to "severe".
Time frame: Day 120-180 both eyes
Near Activity Visual Questionnaire (NAVQ) quality of vision at Visit 4
Quality of vision based on response (choice of 0-3 with 0 meaning no difficulty and 3 meaning extreme difficulty) to each question in the Near Activity Visual Questionnaire (NAVQ) at Visit 4.
Time frame: Day 120-180 both eyes
Safety Endpoint: Rates of AEs (Adverse Events)
Rates of posterior chamber IOL adverse events compared to the ISO Safety and Performance Endpoint (SPE) rates as described in International Organization for Standardization (ISO) 11979-7
Time frame: Enrollment (Day -30 to -1) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
Safety Endpoint: Optical and Visual Symptoms Assessed with NAVQ
Subject questionnaire frequency of optical and visual symptoms as reported in NAVQ
Time frame: Visit 4 (Day 120 to 180 both eyes)
Safety Endpoint: Optical and Visual Symptoms Assessed with QoV questionnaire
Subject questionnaire frequency of optical and visual symptoms as reported in QOV questionnaire
Time frame: Visit 4 (Day 120 to 180 both eyes)
Safety Endpoint: Secondary Surgical Interventions
Rates of device-related secondary surgical interventions related to the POD L GF trifocal IOL
Time frame: Operative Visit (Day 0) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
Safety Endpoint: Serious Adverse Events
The rate of serious adverse events related to teh POD L GF trifocal IOL in first implanted eyes through Visit 5
Time frame: Day 330 to 420 both eyes
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Jul 2022, 37 months.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 37 months is above that.
Counting every sponsor, half of 493 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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