Macular Degeneration, Age RelatedEMERGINGNCT05988827
Effect of Minimizing Light Exposure Intensity on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD
A study testing NGenuity in people with Macular Degeneration, Age Related and Cataract, run by Elsan at 1 site in France.
Trial summary
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The microscope light-induced retinal toxicity after cataract surgery has been described in several reports even in short procedures; however, this potential toxicity has not been evaluated by objective criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration, Age Related, Cataract
- What is being tested?
- NGenuity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2023to 9 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing cataract surgery and presenting signs of early AMD with medium-sized drusen (between 63 µm and 125 µm in diameter) or intermediate AMD with large drusen (>125 µm) or pigmentary abnormalities with at least medium sized drusen in the study eye.
- Patient affiliated to health care system
- Patient with signed informed consent
Who cannot join
- Children under 18 years old
- AMD defined by geographic atrophy or pigment epithelium detachment, subretinal hemorrhage or visible subretinal new vessel, or subretinal fibrous scars in the study eye
- Non-age-related cataracts
- History of previous ocular surgery, anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, neovascular AMD, glaucoma in the study eye
- Any current anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction.
- Patient with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL
Show all 12Show fewer
- Patient treated by plaquenil
- Patient already enrolled in the same study for one eye
- Patient already enrolled in clinical trial or with exclusion period in progress
- Patient under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Minimizing Light Exposure Intensity of 3D Digital Visualization (NGenuity) on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD: A Comparative ERG
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The microscope light-induced retinal toxicity after cataract surgery has been described in several reports even in short procedures; however, this potential toxicity has not been evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly patients with cataract.
The aim of the study will be to assess the potential functional macular effects by focal and multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly address eyes at risk for macular toxicity like patients with early or intermediate AMD
Read the detailed description
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The development of phacoemulsification technology, instrumentation and surgical techniques has improved both the efficacy and safety of procedures, reducing rates of serious postoperative adverse events. The microscope light-induced retinal toxicity after cataract surgery has been described in several reports even in short procedures; however, this potential toxicity has not been evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly patients with cataract. A systematic literature review of 129 664 individuals estimated the prevalence of early macular degeneration to 8.01% in population aged 45 to 85 years. A three-dimensional (3D) heads-up system (NGenuity®, Alcon, Fort Worth, TX) was recently introduced for both vitreoretinal and cataract surgery, radically improving the quality of surgical visualization. This system allows performing cataract surgery at a lower fraction of light intensity reducing patient's photophobia complaints during surgery and probably preventing potential phototoxic macular injury in cataract surgery. In a recent pilot study, the Ngenuity system was reported to decrease significantly the operative light intensity and to contribute to a faster visual recovery relative to traditional microscopes in series of 35 patients (51 eyes) who underwent cataract surgery. The aim of the study will be to assess the potential functional macular effects by focal and multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly address eyes at risk for macular toxicity like patients :
- with early AMD: medium-sized drusen (between 63µm and 125µm in diameter) without pigmentary abnormalities
- with intermediate AMD : large drusen (>125 µm) or pigmentary abnormalities in the retina associated with at least medium drusen
- Conditions
- Macular Degeneration, Age Related, Cataract
- Being tested
- NGenuity
- Keywords
- Cataract, AMD, light exposure
- Medical subject headings
- Macular Degeneration, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGenuityDevice
Cataract surgery performed under microscope using NGenuity
| Study group | Role | What they receive |
|---|---|---|
| NGenuity | Experimental | NGenuity allowing a reduced light intensity to 15% during cataract surgery Receives: Device: NGenuity |
| SOM | No intervention | microscope without NGenuity with light intensity of 60%, similar to a Standad Operating Microscope (SOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the change from baseline of the retinal response amplitude in voltage in patients one hour after cataract surgery performed with NGenuity compared to standard light condition with SOM.
The change from baseline of the photopic b-wave amplitude (µV) measured one hour after the cataract surgery by fERG.
Measured: 1 hour after cataract surgery
Secondary outcomes (4)
Assess the change from baseline in both arms of amplitude of the response in voltage in patients one day and one month after cataract surgery
The change from baseline of photopic b-wave amplitude (µV) measured at postoperative day and 1 month after surgery by fERG
Measured: 1 day and 1 month after cataract surgery
Assess the change from baseline in both arms of latency of response in time in patients one hour, one day and one month after cataract surgery
The change from baseline in both arms of fERG implicit time (msec) measured at one hour, one day and one month after cataract surgery
Measured: 1 hour, 1 day and 1 month after cataract surgery
Assess the change from baseline in both arms of total photoreceptors response in the macula one day and one month after cataract surgery
The change from baseline in both arms of Multifocal ERG amplitude (µV) measured at one day and one month after cataract surgery
Measured: 1 day and 1 month after cataract surgery
Assess the change from baseline in both arms of visual acuity one hour, one day and one month after cataract surgery.
The change from baseline in both arms of visual acuity measured on 10 scale one hour, one day and one month after cataract surgery.
Measured: 1 hour, 1 day and 1 month after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start14 Sep 2023
- Primary completion10 Jul 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, Age RelatedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, 2-arm controlled, parallel, single-masked, single-center study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Otman Sandali, MD, Principal investigator, Hopital Prive Guillaume de Varye ELSAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988827
- Sponsor's protocol ID
- 2023-A00815-40
- Acronym
- EMERGING
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minimizing Light Exposure Intensity of 3D Digital Visualization (NGenuity) on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD: A Comparative ERG
- ClinicalTrials.gov ID
- NCT05988827
- Acronym / sponsor ID
- EMERGING / 2023-A00815-40
- Conditions
- Macular Degeneration, Age Related, Cataract
- Keywords
- Cataract, AMD, light exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The microscope light-induced retinal toxicity after cataract surgery has been described in several reports even in short procedures; however, this potential toxicity has not been evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly patients with cataract.
The aim of the study will be to assess the potential functional macular effects by focal and multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly address eyes at risk for macular toxicity like patients with early or intermediate AMD
Detailed description
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The development of phacoemulsification technology, instrumentation and surgical techniques has improved both the efficacy and safety of procedures, reducing rates of serious postoperative adverse events. The microscope light-induced retinal toxicity after cataract surgery has been described in several reports even in short procedures; however, this potential toxicity has not been evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly patients with cataract. A systematic literature review of 129 664 individuals estimated the prevalence of early macular degeneration to 8.01% in population aged 45 to 85 years. A three-dimensional (3D) heads-up system (NGenuity®, Alcon, Fort Worth, TX) was recently introduced for both vitreoretinal and cataract surgery, radically improving the quality of surgical visualization. This system allows performing cataract surgery at a lower fraction of light intensity reducing patient's photophobia complaints during surgery and probably preventing potential phototoxic macular injury in cataract surgery. In a recent pilot study, the Ngenuity system was reported to decrease significantly the operative light intensity and to contribute to a faster visual recovery relative to traditional microscopes in series of 35 patients (51 eyes) who underwent cataract surgery. The aim of the study will be to assess the potential functional macular effects by focal and multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly address eyes at risk for macular toxicity like patients :
- with early AMD: medium-sized drusen (between 63µm and 125µm in diameter) without pigmentary abnormalities
- with intermediate AMD : large drusen (>125 µm) or pigmentary abnormalities in the retina associated with at least medium drusen
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, 2-arm controlled, parallel, single-masked, single-center study
| Arm | Type | Receives |
|---|---|---|
| NGenuity | Experimental | Device: NGenuityNGenuity allowing a reduced light intensity to 15% during cataract surgery |
| SOM | No intervention | –microscope without NGenuity with light intensity of 60%, similar to a Standad Operating Microscope (SOM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing cataract surgery and presenting signs of early AMD with medium-sized drusen (between 63 µm and 125 µm in diameter) or intermediate AMD with large drusen (>125 µm) or pigmentary abnormalities with at least medium sized drusen in the study eye.
- Patient affiliated to health care system
- Patient with signed informed consent
Key exclusion criteria (12 listed)
- Children under 18 years old
- AMD defined by geographic atrophy or pigment epithelium detachment, subretinal hemorrhage or visible subretinal new vessel, or subretinal fibrous scars in the study eye
- Non-age-related cataracts
- History of previous ocular surgery, anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, neovascular AMD, glaucoma in the study eye
- Any current anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction.
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 |
|---|---|---|
| NGenuityCataract surgery performed under microscope using NGenuity | Device | NGenuity |
Primary outcome
Assess the change from baseline of the retinal response amplitude in voltage in patients one hour after cataract surgery performed with NGenuity compared to standard light condition with SOM.
Time frame: 1 hour after cataract surgery
The change from baseline of the photopic b-wave amplitude (µV) measured one hour after the cataract surgery by fERG.
4 secondary outcomes
Assess the change from baseline in both arms of amplitude of the response in voltage in patients one day and one month after cataract surgery
Time frame: 1 day and 1 month after cataract surgery
Assess the change from baseline in both arms of latency of response in time in patients one hour, one day and one month after cataract surgery
Time frame: 1 hour, 1 day and 1 month after cataract surgery
Assess the change from baseline in both arms of total photoreceptors response in the macula one day and one month after cataract surgery
Time frame: 1 day and 1 month after cataract surgery
Assess the change from baseline in both arms of visual acuity one hour, one day and one month after cataract surgery.
Time frame: 1 hour, 1 day and 1 month after cataract 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 3 Sep 2024.
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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.
Otman Sandali, MD principal investigator
Hopital Prive Guillaume de Varye ELSAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGenuity in people with Macular Degeneration, Age Related and Cataract, run by Elsan at 1 site in France.
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 3 inclusion and 12 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 3 Sep 2024. 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 France. 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?
Assess the change from baseline of the retinal response amplitude in voltage in patients one hour after cataract surgery performed with NGenuity compared to standard light condition with SOM. (time frame: 1 hour after cataract surgery). 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 3 Sep 2024.