CataractMonoeDOFNCT04631068
Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL
A study testing Cataract surgery in people with Cataract, run by Advanced Vision Science, Inc. at 3 sites in 3 countries.
Trial summary
Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Sep 2020to 17 Mar 2023
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 22 years of age and older at the time of consent.
- Cataracts in both eyes.
- Expected post-operative refractive astigmatism of ≤ 1.0 D.
- Calculated lens power from 18 D to 30 D for both study IOLs.
- Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months.
- Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by phacoemulsification cataract extraction in both eyes.
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- Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery.
- Preoperative best corrected distance visual acuity (BCDVA) of 20/32 or worse, with or without a glare source, or preoperative BCDVA of 20/25 or worse with patient complaining of severe visual disturbances attributable to cataract.
- Post-operative BCVA projected to be 0.2 LogMAR or better (as determined by the medical judgment of the Investigator or measured by potential acuity meter / retinal acuity meter (PAM / RAM) if necessary).
- Pharmacologically dilated pupil size at least 6.0 mm.
- Must be able to understand and provide informed consent themselves or through a representative with a witness present on the IRB or EC approved Informed Consent Form (ICF).
Who cannot join
- Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
- Pregnancy or lactation.
- Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms - CRF's).
- Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
- History of any intraocular or corneal surgery in either eye (including LASIK, PRK, etc.).
- Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye.
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- Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis, aniridia, rubeosis iridis, clinically significant corneal disease, Fuchs, or anterior membrane dystrophies, etc.) in either eye.
- Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
- Any visually significant intraocular media opacity other than cataract in either eye.
- History of any clinically significant retinal pathology or ocular diagnosis (e.g., diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, amblyopia, optic neuropathy, microphthalmos, aniridia, etc.) in either eye that could alter or limit final postoperative visual prognosis.
- History of cystoid macular edema in either eye.
- Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements.
- Uncontrolled (e.g., non-medicated) glaucoma in either eye.
- Extremely shallow anterior chamber (< 2.0 mm).
- Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes.
- Irregular astigmatism, corneal degeneration or dystrophy.
- Uncontrolled systemic disease (e.g., diabetes mellitus, active cancer treatment, mental illness, etc.) in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits.
- Systemic medication that, in the opinion of the investigator, may confound the outcome or increase the intraoperative and post-operative risk to the subject (e.g., Tamsulosin Hydrochloride) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g., small pupil/floppy iris syndrome).
- Subjects who may reasonably be expected to require any additional ophthalmic surgical intervention at any time during the study (other than YAG capsulotomy).
- Need for concomitant procedures (e.g., glaucoma surgery, RK, LASIK, etc.).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL
Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens.
Primary Objectives:
- To evaluate the distance VA of the study IOLs
- To evaluate the intermediate VA of the study IOLs
- To explore the safety profile with regards to visual disturbances
Read the detailed description
This study is aimed at patients who have a cloudy lens in both of their eyes, and are eligible for cataract surgery with implantation of an intraocular lens. Patients should be otherwise healthy with no other eye diseases.
The study will take place in 3 centers in Europe, including Oxford Eye Hospital, a part of Oxford University Hospitals NHS Trust and will include 70 patients in total.
The aim of the study is to investigate the safety and effectiveness of a new Intraocular Lens (IOL): the Monofocal Extended Depth of Focus (Mono-EDoF ME4) IOL and to compare it to a standard Monofocal IOL (TECNIS ZBC00). Patients participating will be randomised to either receive the Mono-EDoF ME4 IOL in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL.
Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses.
Total duration of clinical investigation is 12 months and the total expected duration for each patient is 8 months.
Patients will be screened for eligibility preoperatively obtaining a medical history and to establish a baseline ocular condition. Surgeries will be performed on different dates for both eyes but not more than one month apart. The patient will need to return to for seven follow-up visits after eye surgery where vision and health of the eye will be assessed.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Small incision cataract surgery with implantation of an intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Santen xact Mono-EDoF ME4 Intraocular Lens (IOL) | Active comparator | The Monofocal Extended Depth of Focus (Mono-EDoF) posterior chamber foldable intraocular lens is ultraviolet and blue-light absorbing designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. The diffractive technology of the IOL allows most of the light to converge in one focal point thereby providing high quality of distance vision and continuous focus to intermediate vision while minimizing the effects of unwanted visual disturbances. The visual quality is expected to be similar to monofocal IOLs.
Surgery to implant the Mono-EDoF ME4 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification. Receives: Procedure: Cataract surgery |
| J&J TECNIS ZCB00 Intraocular Lens (IOL) | Placebo comparator | The TECNIS 1-Piece Intraocular Lens (IOL), Model ZCB00, is a standard monofocal ultraviolet light absorbing posterior chamber IOL, which is designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens.
Surgery to implant the TECNIS ZCB00 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification. Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Uncorrected Distance VA at Visit 4 (Month 3)
Monocular uncorrected distance visual acuity measured using ETDRS visual acuity chart
Measured: 80-100 days after second eye surgery
Secondary outcomes (2)
Monocular Distance Corrected Intermediate VA at Visit 4 (Month 3)
Subject's vision is corrected for distance and then subject's intermediate vision is measured using a 66-cm ETDRS chart.
Measured: 80-100 days after second eye surgery
Monocular Uncorrected Intermediate VA at Visit 4 (Month 3)
Intermediate Visual Acuity is measured using a 66-cm ETDRS chart.
Measured: 80-100 days after second eye surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start21 Sep 2020
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients participating will be randomised to either receive the Mono-EDoF ME4 Intraocular Lens (IOL) in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL. Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Vision Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Packer, MD, Study chair, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631068
- Sponsor's protocol ID
- AVS CP-7944
- Acronym
- MonoeDOF
- Status last verified
- Jun 2024
- First submitted
- 22 Oct 2019
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Black S. Successful Restoration of Visual Acuity with an Extended Range of Vision Intraocular Lens after Multifocal Laser Ablation. Case Rep Ophthalmol. 2016 Oct 11;7(3):193-197. doi: 10.1159/000450675. eCollection 2016 Sep-Dec.
PubMed 28101037Bostanci Ceran B, Takmaz T, Can I, Demirok G, Uysal BS. Clinical outcomes and optical performance of four differentmultifocal intraocular lenses. Turk J Med Sci. 2016 Apr 19;46(3):597-603. doi: 10.3906/sag-1403-24.
PubMed 27513232Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16. doi: 10.1016/j.ophtha.2008.04.017. Epub 2008 Jun 5.
PubMed 18538402Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. doi: 10.1016/j.jcrs.2016.06.033.
PubMed 27697244Davison JA, Simpson MJ. History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg. 2006 May;32(5):849-58. doi: 10.1016/j.jcrs.2006.02.006.
PubMed 16765805de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.
PubMed 27943250Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.e2. doi: 10.1016/j.ophtha.2007.08.042. Epub 2007 Nov 26.
PubMed 18031818Hashemi H, Khabazkhoob M, Soroush S, Shariati R, Miraftab M, Yekta A. The location of incision in cataract surgery and its impact on induced astigmatism. Curr Opin Ophthalmol. 2016 Jan;27(1):58-64. doi: 10.1097/ICU.0000000000000223.
PubMed 26569524Kaymak H, Hohn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.
PubMed 27385257Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual performance with accommodating and multifocal intraocular lenses. Int J Ophthalmol. 2017 Feb 18;10(2):235-240. doi: 10.18240/ijo.2017.02.09. eCollection 2017.
PubMed 28251082Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.
PubMed 27400074Prasher P, Sandhu JS. Prevalence of corneal astigmatism before cataract surgery in Indian population. Int Ophthalmol. 2017 Jun;37(3):683-689. doi: 10.1007/s10792-016-0327-z. Epub 2016 Aug 27.
PubMed 27567924TECNIS Symfony DFU
Ruiz-Mesa R, Abengozar-Vela A, Aramburu A, Ruiz-Santos M. Comparison of visual outcomes after bilateral implantation of extended range of vision and trifocal intraocular lenses. Eur J Ophthalmol. 2017 Jun 26;27(4):460-465. doi: 10.5301/ejo.5000935. Epub 2017 Jan 28.
PubMed 28165609Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.
PubMed 26796456
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL
- ClinicalTrials.gov ID
- NCT04631068
- Acronym / sponsor ID
- MonoeDOF / AVS CP-7944
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Advanced Vision Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 17 Nov 2020 (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.
Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens.
Primary Objectives:
- To evaluate the distance VA of the study IOLs
- To evaluate the intermediate VA of the study IOLs
- To explore the safety profile with regards to visual disturbances
Detailed description
This study is aimed at patients who have a cloudy lens in both of their eyes, and are eligible for cataract surgery with implantation of an intraocular lens. Patients should be otherwise healthy with no other eye diseases.
The study will take place in 3 centers in Europe, including Oxford Eye Hospital, a part of Oxford University Hospitals NHS Trust and will include 70 patients in total.
The aim of the study is to investigate the safety and effectiveness of a new Intraocular Lens (IOL): the Monofocal Extended Depth of Focus (Mono-EDoF ME4) IOL and to compare it to a standard Monofocal IOL (TECNIS ZBC00). Patients participating will be randomised to either receive the Mono-EDoF ME4 IOL in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL.
Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses.
Total duration of clinical investigation is 12 months and the total expected duration for each patient is 8 months.
Patients will be screened for eligibility preoperatively obtaining a medical history and to establish a baseline ocular condition. Surgeries will be performed on different dates for both eyes but not more than one month apart. The patient will need to return to for seven follow-up visits after eye surgery where vision and health of the eye will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients participating will be randomised to either receive the Mono-EDoF ME4 Intraocular Lens (IOL) in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL. Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses.
| Arm | Type | Receives |
|---|---|---|
| Santen xact Mono-EDoF ME4 Intraocular Lens (IOL) | Active comparator | Procedure: Cataract surgeryThe Monofocal Extended Depth of Focus (Mono-EDoF) posterior chamber foldable intraocular lens is ultraviolet and blue-light absorbing designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. The diffractive technology of the IOL allows most of the light to converge in one focal point thereby providing high quality of distance vision and continuous focus to intermediate vision while minimizing the effects of unwanted visual disturbances. The visual quality is expected to be similar to monofocal IOLs. Surgery to implant the Mono-EDoF ME4 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification. |
| J&J TECNIS ZCB00 Intraocular Lens (IOL) | Placebo comparator | Procedure: Cataract surgeryThe TECNIS 1-Piece Intraocular Lens (IOL), Model ZCB00, is a standard monofocal ultraviolet light absorbing posterior chamber IOL, which is designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. Surgery to implant the TECNIS ZCB00 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults 22 years of age and older at the time of consent.
- Cataracts in both eyes.
- Expected post-operative refractive astigmatism of ≤ 1.0 D.
- Calculated lens power from 18 D to 30 D for both study IOLs.
- Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months.
Key exclusion criteria (20 listed)
- Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
- Pregnancy or lactation.
- Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms - CRF's).
- Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
- History of any intraocular or corneal surgery in either eye (including LASIK, PRK, etc.).
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 |
|---|---|---|
| Cataract surgerySmall incision cataract surgery with implantation of an intraocular lens | Procedure or surgery | J&J TECNIS ZCB00 Intraocular Lens (IOL), Santen xact Mono-EDoF ME4 Intraocular Lens (IOL) |
Primary outcome
Monocular Uncorrected Distance VA at Visit 4 (Month 3)
Time frame: 80-100 days after second eye surgery
Monocular uncorrected distance visual acuity measured using ETDRS visual acuity chart
2 secondary outcomes
Monocular Distance Corrected Intermediate VA at Visit 4 (Month 3)
Time frame: 80-100 days after second eye surgery
Monocular Uncorrected Intermediate VA at Visit 4 (Month 3)
Time frame: 80-100 days after second eye 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 11 Jun 2024.
- Background: PubMed 28101037Black S. Successful Restoration of Visual Acuity with an Extended Range of Vision Intraocular Lens after Multifocal Laser Ablation. Case Rep Ophthalmol. 2016 Oct 11;7(3):193-197. doi: 10.1159/000450675. eCollection 2016 Sep-Dec.
- Background: PubMed 27513232Bostanci Ceran B, Takmaz T, Can I, Demirok G, Uysal BS. Clinical outcomes and optical performance of four differentmultifocal intraocular lenses. Turk J Med Sci. 2016 Apr 19;46(3):597-603. doi: 10.3906/sag-1403-24.
- Background: PubMed 18538402Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16. doi: 10.1016/j.ophtha.2008.04.017. Epub 2008 Jun 5.
- Background: PubMed 27697244Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. doi: 10.1016/j.jcrs.2016.06.033.
- Background: PubMed 16765805Davison JA, Simpson MJ. History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg. 2006 May;32(5):849-58. doi: 10.1016/j.jcrs.2006.02.006.
- Background: PubMed 27943250de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.
- Background: PubMed 18031818Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.e2. doi: 10.1016/j.ophtha.2007.08.042. Epub 2007 Nov 26.
- Background: PubMed 26569524Hashemi H, Khabazkhoob M, Soroush S, Shariati R, Miraftab M, Yekta A. The location of incision in cataract surgery and its impact on induced astigmatism. Curr Opin Ophthalmol. 2016 Jan;27(1):58-64. doi: 10.1097/ICU.0000000000000223.
- Background: PubMed 27385257Kaymak H, Hohn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.
- Background: PubMed 28251082Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual performance with accommodating and multifocal intraocular lenses. Int J Ophthalmol. 2017 Feb 18;10(2):235-240. doi: 10.18240/ijo.2017.02.09. eCollection 2017.
- Background: PubMed 27400074Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.
- Background: PubMed 27567924Prasher P, Sandhu JS. Prevalence of corneal astigmatism before cataract surgery in Indian population. Int Ophthalmol. 2017 Jun;37(3):683-689. doi: 10.1007/s10792-016-0327-z. Epub 2016 Aug 27.
- 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.
Mark Packer, MD study chair
Medical Monitor
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Cataract, run by Advanced Vision Science, Inc. at 3 sites in 3 countries.
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 11 inclusion and 20 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Portugal, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Monocular Uncorrected Distance VA at Visit 4 (Month 3) (time frame: 80-100 days after second eye surgery). 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 NCT04631068, which also lists 18 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 11 Jun 2024.