An interventional study of cataract surgery with Centurion phacoemulsification system and cataract surgery with Quatera 700 phacoemulsification system in Cataract, sponsored by Amphia Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Amphia Hospital · Not applicable, Interventional, and Treatment
The goal of this study is to study the restoration of quality of vision, expressed as straylight, in the immediate period after cataract surgery with two different phacoemulsification technologies.
Cataract is an opacification of the lens. With cataract surgery, the lens is surgically removed after which a clear artificial intraocular lens is implanted. For patients, it is important that they regain functional vision as quickly as possible after surgery as a limited vision may increase the risk of falling and increases the dependency on other people. Surgical removal of the lens is done with a phacoemulsification system. Differences between phacoemulsification systems are the used pump type, the way the needle oscillates, and the fluid dynamics of the system. It is unknown whether any of the available systems offer an advantage on the amount of corneal oedema that develops after surgery and, therefore, results in a more rapid restoration of functional vision.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 15 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Amphia Hospital is the lead sponsor of 13 studies on the registry; 3 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.
Exclusion Criteria:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cataract surgery performed with the Centurion phacoemulsification system
Procedure: cataract surgery with Centurion phacoemulsification system
Cataract surgery performed with the Quatera 700 phacoemulsification system
Procedure: cataract surgery with Quatera 700 phacoemulsification system
Cataract surgery performed with the Centurion phacoemulsification system
Cataract surgery performed with the Quatera 700 phacoemulsification system
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Time frame: preoperative
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Time frame: 1-2 hours after surgery
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Time frame: 1 day after surgery
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Time frame: 1 week after surgery
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Time frame: 1 month after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Time frame: preoperative
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Time frame: 1-2 hours after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Time frame: 1 day after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Time frame: 1 week after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Time frame: 1 month after surgery
Amount of phaco energy used
Amount of phaco energy used, expressed as Cumulative Dissipated Energy (CDE, for Alcon Centurion) or as Equivalent Phaco Time (EPT, for Zeiss Quatera 700)
Time frame: Surgery day
Amount of balanced salt solution used
Amount of balanced salt solution used, expressed in milliliters
Time frame: Surgery day
Total surgery time
Total surgery time per eye
Time frame: Surgery day
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Time frame: preoperative
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Time frame: 1-2 hours after surgery
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Time frame: 1 day after surgery
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Time frame: 1 week after surgery
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Time frame: 1 month after surgery
Corrected Distance Visual Acuity
Corrected Distance Visual Acuity, expressed as logMAR
Time frame: preoperative
Corrected Distance Visual Acuity
Corrected Distance Visual Acuity, expressed as logMAR
Time frame: 1 day after surgery
Corrected Distance Visual Acuity
Corrected Distance Visual Acuity, expressed as logMAR
Time frame: 1 week after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Time frame: 1 month after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Time frame: preoperative
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Time frame: 1-2 hours after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Time frame: 1 day after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Time frame: 1 week after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Time frame: preoperative
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Time frame: 1-2 hours after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Time frame: 1 day after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Time frame: 1 week after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Time frame: 1 month after surgery
Catquest-9SF
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
Time frame: preoperative
Catquest-9SF
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
Time frame: 1-2 hours after surgery
Catquest-9SF
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
Time frame: 1 day after surgery
Catquest-9SF
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
Time frame: 1 week after surgery
Catquest-9SF
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
Time frame: 1 month after surgery
Patient-Perceived Satisfactory Improvement in Vision
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
Time frame: 1-2 hours after surgery
Patient-Perceived Satisfactory Improvement in Vision
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
Time frame: 1 day after surgery
Patient-Perceived Satisfactory Improvement in Vision
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
Time frame: 1 week after surgery
Patient-Perceived Satisfactory Improvement in Vision
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
Time frame: 1 month after surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for Sep 2023, 12 months later.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Amphia Hospital