An interventional study of Alcon phacoemulsification equipment and AMO phacoemulsification equipment in Cataract Surgery, sponsored by Intuor Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by Intuor Technologies, Inc. · Not applicable, Interventional, and Diagnostic
This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.
What is known:
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 15 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Intuor Technologies, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Age 18 or greater
Exclusion Criteria:
Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cataract surgery performed with the Alcon phacoemulsification equipment
Device: Alcon phacoemulsification equipment
cataract surgery with the AMO phacoemulsification equipment
Device: AMO phacoemulsification equipment
cataract surgery with Alcon phacoemulsification equipment.
cataract surgery with AMO phacoemulsification equipment.
Number of Eyes With Stable IOP
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
Time frame: intraoperative
From September 2016 until December 2016,15 patients were enrolled at Arizona Eye Consultants clinic
| Milestone | Alcon Phacoemulsification Equipment | AMO Phacoemulsification Equipment |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
| Eyes | Alcon Phacoemulsification Equipment | AMO Phacoemulsification Equipment |
|---|---|---|
| Number of Eyes With Stable IOP | 16 | 14 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcon Phacoemulsification Equipment | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| AMO Phacoemulsification Equipment | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
16 eyes from 8 subjects for Alcon equipment and 14 eyes from 7 subjects for AMO.
| Age, Continuous(years) | Alcon Phacoemulsification Equipment | AMO Phacoemulsification Equipment | Total |
|---|---|---|---|
| Mean | 66 ± 8 | 66 ± 8 | 66 ± 8 |
| Sex: Female, Male(Participants) | Alcon Phacoemulsification Equipment | AMO Phacoemulsification Equipment | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 3 | 3 | 6 |
| Region of Enrollment(Participants) | Alcon Phacoemulsification Equipment | AMO Phacoemulsification Equipment | Total |
|---|---|---|---|
| United States | 8 | 7 | 15 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intuor Technologies, Inc.