AphakiaNCT04755231
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
A study testing AcrySof IQ PanOptix Presbyopia Correcting IOL and Cataract surgery in people with Aphakia and Presbyopia, run by Alcon Research at 9 sites in China.
Trial summary
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia, Presbyopia
- What is being tested?
- AcrySof IQ PanOptix Presbyopia Correcting IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 9 sitesChina
- Study dates
- 19 Apr 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to comprehend and sign an informed consent form;
- Able to complete all study visits required in the protocol;
- Chinese; diagnosed with cataracts in both eyes;
- Planned bilateral cataract removal by routine phacoemulsification;
- Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
- Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
- Clinically significant corneal diseases;
- Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
- Previous intraocular or corneal surgery;
- Pregnancy or lactation during study or planning to be pregnant/lactating;
- Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
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- Other planned ocular surgical procedures;
- Patients who desire monovision correction.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking University People's Hospital
Beijing, 100044
Beijing Tongren Hospital Capital Medical University
Beijing, 100730
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guandong, 510060
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009
Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine
Shandong, 250002
Eye & ENT Hospital of Fudan University
Shanghai, 200031
Shanxi Eye Hospital
Shanxi, 710068
West China Hospital of Sichuan University
Sichuan, 610041
Tianjin Medical University Eye Hospital
Tianjin, 300384
About this study
Official title: Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
Read the detailed description
In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.
- Conditions
- Aphakia, Presbyopia
- Being tested
- AcrySof IQ PanOptix Presbyopia Correcting IOL, Cataract surgery
- Keywords
- Cataract, Intraocular Lens
- Medical subject headings
- Aphakia, Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ PanOptix Presbyopia Correcting IOLDevice
Also called Model TFNT00
UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.
Cataract surgeryProcedure or surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
| Study group | Role | What they receive |
|---|---|---|
| PanOptix IOL | Experimental | AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery Receives: Device: AcrySof IQ PanOptix Presbyopia Correcting IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Number of Ocular Treatment Emergent Adverse Events
An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Non-Ocular Treatment Emergent Adverse Events
An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Secondary Surgical Interventions
A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint.
Measured: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start19 Apr 2021
- Primary completion31 Aug 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphakiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Project Manager, Surgical, Study director, Alcon (China) Ophthalmic Product Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755231
- Sponsor's protocol ID
- ILH297-C004
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2021
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
- ClinicalTrials.gov ID
- NCT04755231
- Acronym / sponsor ID
- ILH297-C004
- Conditions
- Aphakia, Presbyopia
- Keywords
- Cataract, Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
Detailed description
In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PanOptix IOL | Experimental | Device: AcrySof IQ PanOptix Presbyopia Correcting IOL, Procedure: Cataract surgeryAcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to comprehend and sign an informed consent form;
- Able to complete all study visits required in the protocol;
- Chinese; diagnosed with cataracts in both eyes;
- Planned bilateral cataract removal by routine phacoemulsification;
- Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
Key exclusion criteria (9 listed)
- Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
- Clinically significant corneal diseases;
- Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
- Previous intraocular or corneal surgery;
- Pregnancy or lactation during study or planning to be pregnant/lactating;
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 |
|---|---|---|
| AcrySof IQ PanOptix Presbyopia Correcting IOLAlso: Model TFNT00UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China. | Device | PanOptix IOL |
| Cataract surgeryCataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL | Procedure or surgery | PanOptix IOL |
Primary outcome
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.
Number of Ocular Treatment Emergent Adverse Events
Time frame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.
Number of Non-Ocular Treatment Emergent Adverse Events
Time frame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.
Number of Secondary Surgical Interventions
Time frame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint.
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint.
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sr. Clinical Project Manager, Surgical study director
Alcon (China) Ophthalmic Product Co., Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof IQ PanOptix Presbyopia Correcting IOL and Cataract surgery in people with Aphakia and Presbyopia, run by Alcon Research at 9 sites in China.
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 8 inclusion and 9 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular (time frame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)). The study lists 13 primary outcomes in all. 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 10 Oct 2023.