CataractNCT05489198
Cataract Surgery Technique and Ocular Clarity
A study testing cataract surgery with Centurion phacoemulsification system and cataract surgery with Quatera 700 phacoemulsification system in people with Cataract, run by Amphia Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery with Centurion phacoemulsification system and cataract surgery with Quatera 700 phacoemulsification system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2023
- 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
- Diagnosis of cataract in both eyes,
- Having consented to and is planned to undergo cataract surgery in both eyes,
- Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
- A targeted refractive error of emmetropia,
- Corneal astigmatism of ≤1.5 D,
- Age of at least 18 years,
- Willing and able to participate in both preoperative and postoperative examinations, and
- Agreeing to sign the informed consent form.
Who cannot join
- Insufficient understanding of the Dutch language to comply with study procedures,
- Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
- Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
- Subjects with an increased risk of complicated cataract surgery:
- Lens subluxation or (phaco)iridodonesis,
- Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
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- History of ocular trauma,
- Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
- A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems
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.
Read the detailed description
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.
- Conditions
- Cataract
- Being tested
- cataract surgery with Centurion phacoemulsification system, cataract surgery with Quatera 700 phacoemulsification system
- Keywords
- Straylight, Phacoemulsification, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgery with Centurion phacoemulsification systemProcedure or surgery
Cataract surgery performed with the Centurion phacoemulsification system
cataract surgery with Quatera 700 phacoemulsification systemProcedure or surgery
Cataract surgery performed with the Quatera 700 phacoemulsification system
| Study group | Role | What they receive |
|---|---|---|
| Centurion | Experimental | Cataract surgery performed with the Centurion phacoemulsification system Receives: Procedure: cataract surgery with Centurion phacoemulsification system |
| Quatera 700 | Experimental | Cataract surgery performed with the Quatera 700 phacoemulsification system Receives: Procedure: cataract surgery with Quatera 700 phacoemulsification system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Measured: preoperative
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Measured: 1-2 hours after surgery
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Measured: 1 day after surgery
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Measured: 1 week after surgery
Straylight
Amount of straylight measured with C-Quant, expressed as log(s)
Measured: 1 month after surgery
Secondary outcomes (35)
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Measured: preoperative
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Measured: 1-2 hours after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Measured: 1 day after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Measured: 1 week after surgery
Corneal densitometry
Corneal densitometry measured with Pentacam, expressed as percentage
Measured: 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)
Measured: Surgery day
Amount of balanced salt solution used
Amount of balanced salt solution used, expressed in milliliters
Measured: Surgery day
Total surgery time
Total surgery time per eye
Measured: Surgery day
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Measured: preoperative
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Measured: 1-2 hours after surgery
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Measured: 1 day after surgery
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Measured: 1 week after surgery
Uncorrected Distance Visual Acuity
Uncorrected Distance Visual Acuity, expressed as logMAR
Measured: 1 month after surgery
Corrected Distance Visual Acuity
Corrected Distance Visual Acuity, expressed as logMAR
Measured: preoperative
Corrected Distance Visual Acuity
Corrected Distance Visual Acuity, expressed as logMAR
Measured: 1 day after surgery
Corrected Distance Visual Acuity
Corrected Distance Visual Acuity, expressed as logMAR
Measured: 1 week after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Measured: 1 month after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Measured: preoperative
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Measured: 1-2 hours after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Measured: 1 day after surgery
Corneal pachymetry
Corneal thickness measured with Pentacam, expressed as um
Measured: 1 week after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Measured: preoperative
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Measured: 1-2 hours after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Measured: 1 day after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Measured: 1 week after surgery
Presence of corneal oedema
Presence of corneal oedema with slit lamp biomicroscopy
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, comparative, single-arm, randomised, and single-centre study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nic J. Reus, MD, PhD, Amphia Hospital
- Investigators
- Nic J. Reus, MD, PhD, Principal investigator, Amphia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489198
- Sponsor's protocol ID
- 1900
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems
- ClinicalTrials.gov ID
- NCT05489198
- Acronym / sponsor ID
- 1900
- Conditions
- Cataract
- Keywords
- Straylight, Phacoemulsification, Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, comparative, single-arm, randomised, and single-centre study
| Arm | Type | Receives |
|---|---|---|
| Centurion | Experimental | Procedure: cataract surgery with Centurion phacoemulsification systemCataract surgery performed with the Centurion phacoemulsification system |
| Quatera 700 | Experimental | Procedure: cataract surgery with Quatera 700 phacoemulsification systemCataract surgery performed with the Quatera 700 phacoemulsification system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cataract in both eyes,
- Having consented to and is planned to undergo cataract surgery in both eyes,
- Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
- A targeted refractive error of emmetropia,
- Corneal astigmatism of ≤1.5 D,
Key exclusion criteria (9 listed)
- Insufficient understanding of the Dutch language to comply with study procedures,
- Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
- Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
- Subjects with an increased risk of complicated cataract surgery:
- Lens subluxation or (phaco)iridodonesis,
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 |
|---|---|---|
| cataract surgery with Centurion phacoemulsification systemCataract surgery performed with the Centurion phacoemulsification system | Procedure or surgery | Centurion |
| cataract surgery with Quatera 700 phacoemulsification systemCataract surgery performed with the Quatera 700 phacoemulsification system | Procedure or surgery | Quatera 700 |
Primary outcome
Straylight
Time frame: preoperative
Amount of straylight measured with C-Quant, expressed as log(s)
Straylight
Time frame: 1-2 hours after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
Straylight
Time frame: 1 day after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
Straylight
Time frame: 1 week after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
Straylight
Time frame: 1 month after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
35 secondary outcomes
Corneal densitometry
Time frame: preoperative
Corneal densitometry
Time frame: 1-2 hours after surgery
Corneal densitometry
Time frame: 1 day after surgery
Corneal densitometry
Time frame: 1 week after surgery
Corneal densitometry
Time frame: 1 month after surgery
Amount of phaco energy used
Time frame: Surgery day
Amount of balanced salt solution used
Time frame: Surgery day
Total surgery time
Time frame: Surgery day
Uncorrected Distance Visual Acuity
Time frame: preoperative
Uncorrected Distance Visual Acuity
Time frame: 1-2 hours after surgery
Uncorrected Distance Visual Acuity
Time frame: 1 day after surgery
Uncorrected Distance Visual Acuity
Time frame: 1 week after surgery
Uncorrected Distance Visual Acuity
Time frame: 1 month after surgery
Corrected Distance Visual Acuity
Time frame: preoperative
Corrected Distance Visual Acuity
Time frame: 1 day after surgery
Corrected Distance Visual Acuity
Time frame: 1 week after surgery
Corneal pachymetry
Time frame: 1 month after surgery
Corneal pachymetry
Time frame: preoperative
Corneal pachymetry
Time frame: 1-2 hours after surgery
Corneal pachymetry
Time frame: 1 day after surgery
Corneal pachymetry
Time frame: 1 week after surgery
Presence of corneal oedema
Time frame: preoperative
Presence of corneal oedema
Time frame: 1-2 hours after surgery
Presence of corneal oedema
Time frame: 1 day after surgery
Presence of corneal oedema
Time frame: 1 week after surgery
Presence of corneal oedema
Time frame: 1 month after surgery
Catquest-9SF
Time frame: preoperative
Catquest-9SF
Time frame: 1-2 hours after surgery
Catquest-9SF
Time frame: 1 day after surgery
Catquest-9SF
Time frame: 1 week after surgery
Catquest-9SF
Time frame: 1 month after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time frame: 1-2 hours after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time frame: 1 day after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time frame: 1 week after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- 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.
Nic J. Reus, MD, PhD principal investigator
Amphia Hospital
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery with Centurion phacoemulsification system and cataract surgery with Quatera 700 phacoemulsification system in people with Cataract, run by Amphia Hospital.
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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nic J. Reus, MD, PhD (+31765952239, nreus@amphia.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Straylight (time frame: preoperative). The study lists 5 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 5 Aug 2022.