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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGenuity | Experimental | NGenuity 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGenuity | Device | Cataract surgery performed under microscope using NGenuity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour after cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day and 1 month after cataract surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Otman Sandali, MD | Hopital Prive Guillaume de Varye ELSAN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital privé Guillaume de Varye | Saint-Doulchard | 18230 | France |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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Prospective, randomized, 2-arm controlled, parallel, single-masked, single-center study
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Participant is not aware about the light exposure used during the surgery (NGenuity or SOM)
| 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 |
| 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 | 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. | 1 hour, 1 day and 1 month after cataract surgery |