Nuclear CataractNCT05765201
Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
An observational study of Nuclear Cataract, run by Matthew Rauen at 1 site in United States.
Trial summary
The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nuclear Cataract
- What is being tested?
- High IOP and Low IOP
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 4 May 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 25 cataract surgery patients form ophthalmology clinic.
Who may be able to join
- No prior ocular surgery including corneal refractive surgery
- Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
- Equal dilated pupil size ≥6mm, no use of pupil expansion devices
- Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline
- A1C ≤ 8% on single monotherapy or lifestyle adjustments
- To maintain high sensitivity/specificity, patients to fall under OCT normative database:
Show all 12Show fewer
- Axial length 22-26mm
- Refractive error between -5.00D to +5.00D
- Cylinder ≤ 3.00D
- Normal K values <47.00D
- Axial eye length cannot vary by more than 0.4 mm in an individual patient
- Normal CCT range 540µm ± 50
Who cannot join
- H/o corneal disease or dystrophies
- Media opacification for reasons other than cataract
- Compromised zonular integrity or stability
- Retinal and retinal vascular pathologies, age-related macular degeneration
- Glaucoma
- Patients with uncontrolled systematic diseases; including hypertension, diabetes, systemic cardiovascular diseases and hematological diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).
Read the detailed description
To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).
- Conditions
- Nuclear Cataract
- Being tested
- High IOP, Low IOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High IOPOther
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
Low IOPOther
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
| Study group | Role | What they receive |
|---|---|---|
| High IOP | Eyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery. Receives: Other: High IOP | |
| Low IOP | Eyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery. Receives: Other: Low IOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated fluid usage- High IOP Group
Measurement of fluid usage (ml).
Measured: Intraoperative
Estimated fluid usage- Low IOP Group
Measurement of fluid usage (ml).
Measured: Intraoperative
Secondary outcomes (2)
Macular Thickness
Macular thickness measured in microns at week 1, month 1, and month 3. Measured by optical coherence tomography (OCT).
Measured: post procedure at 1 week, 1 month, and 3 months
Corneal Thickness
Corneal thickness measured in microns at 1 day, week 1, month 1, and month 3. Measured by pentacam tomography.
Measured: post procedure at 1 day, 1 week, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start22 Sep 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nuclear 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Rauen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Rauen, Wolfe Eye Clinic
- Investigators
- Matthew Rauen, MD, Principal investigator, Wolfe Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765201
- Sponsor's protocol ID
- Alcon IIT # 75098433
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang Y, Chen X, Zhang X, Tang Q, Liu S, Yao K. Clinical evaluation of corneal changes after phacoemulsification in diabetic and non-diabetic cataract patients, a systematic review and meta-analysis. Sci Rep. 2017 Oct 26;7(1):14128. doi: 10.1038/s41598-017-14656-7.
PubMed 29074989Li T, Guadie A, Feng L, Fan J, Jiang Z, Liu F. Influence of cataract surgery on macular vascular density in patients with myopia using optical coherence tomography angiography. Exp Ther Med. 2020 Dec;20(6):258. doi: 10.3892/etm.2020.9388. Epub 2020 Oct 27.
PubMed 33199984Zeng S, Liang C, He Y, Chen Y, Zhao Q, Dai S, Cheng F, Zhang J, Jiang X. Changes of Subfoveal Choroidal Thickness after Cataract Surgery: A Meta-Analysis. J Ophthalmol. 2018 Nov 12;2018:2501325. doi: 10.1155/2018/2501325. eCollection 2018.
PubMed 30607294Vasavada V, Raj SM, Praveen MR, Vasavada AR, Henderson BA, Asnani PK. Real-time dynamic intraocular pressure fluctuations during microcoaxial phacoemulsification using different aspiration flow rates and their impact on early postoperative outcomes: a randomized clinical trial. J Refract Surg. 2014 Aug;30(8):534-40. doi: 10.3928/1081597X-20140711-06.
PubMed 25325894Chen D, Zhu J, Li J, Ding XX, Lu F, Zhao YE. Effect of simulated dynamic intraocular pressure on retinal thickness measured by optical coherence tomography after cataract surgery. Int J Ophthalmol. 2012;5(6):687-93. doi: 10.3980/j.issn.2222-3959.2012.06.07. Epub 2012 Dec 18.
PubMed 23275902Liu X, Fang Y, Zhou Y, Wang M, Luo Y. Dynamic changes in retinal vessel density observed by optical coherence tomography angiography after phacoemulsification: active vs gravity fluidics system. Arq Bras Oftalmol. 2022 Apr 8;85(2):205-207. doi: 10.5935/0004-2749.20220093. eCollection 2022. No abstract available.
PubMed 35416902
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
- ClinicalTrials.gov ID
- NCT05765201
- Acronym / sponsor ID
- Alcon IIT # 75098433
- Conditions
- Nuclear Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Matthew RauenUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 13 Mar 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.
The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).
Detailed description
To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High IOP | – | Other: High IOPEyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery. |
| Low IOP | – | Other: Low IOPEyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 25 cataract surgery patients form ophthalmology clinic.
Key inclusion criteria (12 listed)
- No prior ocular surgery including corneal refractive surgery
- Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
- Equal dilated pupil size ≥6mm, no use of pupil expansion devices
- Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline
- A1C ≤ 8% on single monotherapy or lifestyle adjustments
Key exclusion criteria (6 listed)
- H/o corneal disease or dystrophies
- Media opacification for reasons other than cataract
- Compromised zonular integrity or stability
- Retinal and retinal vascular pathologies, age-related macular degeneration
- Glaucoma
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 |
|---|---|---|
| High IOPProspective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye | Other | High IOP |
| Low IOPProspective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye | Other | Low IOP |
Primary outcome
Estimated fluid usage- High IOP Group
Time frame: Intraoperative
Measurement of fluid usage (ml).
Estimated fluid usage- Low IOP Group
Time frame: Intraoperative
Measurement of fluid usage (ml).
2 secondary outcomes
Macular Thickness
Time frame: post procedure at 1 week, 1 month, and 3 months
Corneal Thickness
Time frame: post procedure at 1 day, 1 week, 1 month, and 3 months
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 8 Jan 2024.
- Results publication: PubMed 29074989Tang Y, Chen X, Zhang X, Tang Q, Liu S, Yao K. Clinical evaluation of corneal changes after phacoemulsification in diabetic and non-diabetic cataract patients, a systematic review and meta-analysis. Sci Rep. 2017 Oct 26;7(1):14128. doi: 10.1038/s41598-017-14656-7.
- Results publication: PubMed 33199984Li T, Guadie A, Feng L, Fan J, Jiang Z, Liu F. Influence of cataract surgery on macular vascular density in patients with myopia using optical coherence tomography angiography. Exp Ther Med. 2020 Dec;20(6):258. doi: 10.3892/etm.2020.9388. Epub 2020 Oct 27.
- Results publication: PubMed 30607294Zeng S, Liang C, He Y, Chen Y, Zhao Q, Dai S, Cheng F, Zhang J, Jiang X. Changes of Subfoveal Choroidal Thickness after Cataract Surgery: A Meta-Analysis. J Ophthalmol. 2018 Nov 12;2018:2501325. doi: 10.1155/2018/2501325. eCollection 2018.
- Results publication: PubMed 25325894Vasavada V, Raj SM, Praveen MR, Vasavada AR, Henderson BA, Asnani PK. Real-time dynamic intraocular pressure fluctuations during microcoaxial phacoemulsification using different aspiration flow rates and their impact on early postoperative outcomes: a randomized clinical trial. J Refract Surg. 2014 Aug;30(8):534-40. doi: 10.3928/1081597X-20140711-06.
- Results publication: PubMed 23275902Chen D, Zhu J, Li J, Ding XX, Lu F, Zhao YE. Effect of simulated dynamic intraocular pressure on retinal thickness measured by optical coherence tomography after cataract surgery. Int J Ophthalmol. 2012;5(6):687-93. doi: 10.3980/j.issn.2222-3959.2012.06.07. Epub 2012 Dec 18.
- Results publication: PubMed 35416902Liu X, Fang Y, Zhou Y, Wang M, Luo Y. Dynamic changes in retinal vessel density observed by optical coherence tomography angiography after phacoemulsification: active vs gravity fluidics system. Arq Bras Oftalmol. 2022 Apr 8;85(2):205-207. doi: 10.5935/0004-2749.20220093. eCollection 2022. No abstract available.
- 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.
Matthew Rauen, MD principal investigator
Wolfe Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nuclear Cataract, run by Matthew Rauen at 1 site in United States.
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 12 inclusion and 6 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 8 Jan 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 United States. 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?
Estimated fluid usage- High IOP Group (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05765201, which also lists 6 linked publications.
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 8 Jan 2024.