Intraocular PressureNCT00856141
Set up for in-Vivo Measurement of Dynamic Intraocular Pressure (IOP)
A study testing phacoemulsifcation in people with Intraocular Pressure, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
In this modern era, surgeons prefer to perform emulsification through small micro incisions. To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion systems.We believe that this sustained rise in the IOP during micro-incision phacoemulsification for a substantial period could be… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- phacoemulsifcation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2006to May 2006
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing phacoemulsification for uncomplicated senile cataracts
- Cataracts from grade 1 to 3
Who cannot join
- presence of glaucoma,
- diabetic retinopathy,
- retinal vascular disease,
- high myopia (defined as AL > 25mm),
- uveitis,
- previous ocular trauma or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Evaluation of Dynamic IOP Measuring Device During Phacoemulsifcation: A Prospective Randomised Clinical Trial
In this modern era, surgeons prefer to perform emulsification through small micro incisions. To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion systems.We believe that this sustained rise in the IOP during micro-incision phacoemulsification for a substantial period could be detrimental to the ocular structures. Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging concern.
Conventional systems for measuring IOP generate an isolated graph of continuous pressure recording. Interpretation of the IOP fluctuations from these graphs requires a two step superimposition approach to characterize the IOP changes.
Read the detailed description
The aim of the present study was to describe a new setup for intra-operative monitoring of IOP in a clinical setting and validate it by correlating IOP differences arising with different phacoemulsification parameters in eyes undergoing microincision coaxial phacoemulsification.
- Conditions
- Intraocular Pressure
- Being tested
- phacoemulsifcation
- Keywords
- IOP measurement, IOP fluctuation, in-vivo IOP measuring device, intraocular pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsifcationDevice
Also called high aspiration flow rate,, high vacuum
A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
phacoemulsifcationDevice
Also called low flow rate, low vacuum, low bottle height
A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
| Study group | Role | What they receive |
|---|---|---|
| 1. High fluidic parameters | Experimental | Bottle height varied from 90-110cms, fixed aspiration flow rate 40cc/min, vacuum upto 650mmHg depending on the grade of cataract Receives: Device: phacoemulsifcation |
| 2. Low fluidic parameters | Active comparator | Bottle height varied from 70-90cms, fixed aspiration flow rate of 25cc/min, vacuum upto 400mmHg, depending on the grade of cataract Receives: Device: phacoemulsifcation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP fluctuation during each phase of surgery
Measured: intra-operative
Secondary outcomes (1)
comparison of IOP fluctuations between high and low parameters group
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJan 2006
- Primary completionMar 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Abhay R Vasavada, FRCS, Principal investigator, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856141
- Sponsor's protocol ID
- 005-036
- Other IDs
- IOP set up, IOP fluctuations
- Status last verified
- Mar 2009
- First submitted
- 4 Mar 2009
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grinbaum A, Blumenthal M, Assia E. Comparison of intraocular pressure profiles during cataract surgery by phacoemulsification and extracapsular cataract extraction. Ophthalmic Surg Lasers Imaging. 2003 May-Jun;34(3):182-6.
PubMed 12757089Georgescu D, Payne M, Olson RJ. Objective measurement of postocclusion surge during phacoemulsification in human eye-bank eyes. Am J Ophthalmol. 2007 Mar;143(3):437-40. doi: 10.1016/j.ajo.2006.11.017. Epub 2006 Dec 18.
PubMed 17222793Khng C, Packer M, Fine IH, Hoffman RS, Moreira FB. Intraocular pressure during phacoemulsification. J Cataract Refract Surg. 2006 Feb;32(2):301-8. doi: 10.1016/j.jcrs.2005.08.062.
PubMed 16565009Moorhead LC, Gardner TW, Lambert HM, O'Malley RE, Willis AW, Meharg LS, Moorhead WD. Dynamic intraocular pressure measurements during vitrectomy. Arch Ophthalmol. 2005 Nov;123(11):1514-23. doi: 10.1001/archopht.123.11.1514.
PubMed 16286613Joos KM, Kay MD, Pillunat LE, Harris A, Gendron EK, Feuer WJ, Steinwand BE. Effect of acute intraocular pressure changes on short posterior ciliary artery haemodynamics. Br J Ophthalmol. 1999 Jan;83(1):33-8. doi: 10.1136/bjo.83.1.33.
PubMed 10209431
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of Dynamic IOP Measuring Device During Phacoemulsifcation: A Prospective Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00856141
- Acronym / sponsor ID
- 005-036
- Conditions
- Intraocular Pressure
- Keywords
- IOP measurement, IOP fluctuation, in-vivo IOP measuring device, intraocular pressure measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 5 Mar 2009 (estimated)
- 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.
In this modern era, surgeons prefer to perform emulsification through small micro incisions. To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion systems.We believe that this sustained rise in the IOP during micro-incision phacoemulsification for a substantial period could be detrimental to the ocular structures. Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging concern.
Conventional systems for measuring IOP generate an isolated graph of continuous pressure recording. Interpretation of the IOP fluctuations from these graphs requires a two step superimposition approach to characterize the IOP changes.
Detailed description
The aim of the present study was to describe a new setup for intra-operative monitoring of IOP in a clinical setting and validate it by correlating IOP differences arising with different phacoemulsification parameters in eyes undergoing microincision coaxial phacoemulsification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. High fluidic parameters | Experimental | Device: phacoemulsifcationBottle height varied from 90-110cms, fixed aspiration flow rate 40cc/min, vacuum upto 650mmHg depending on the grade of cataract |
| 2. Low fluidic parameters | Active comparator | Device: phacoemulsifcationBottle height varied from 70-90cms, fixed aspiration flow rate of 25cc/min, vacuum upto 400mmHg, depending on the grade of cataract |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing phacoemulsification for uncomplicated senile cataracts
- Cataracts from grade 1 to 3
Key exclusion criteria (6 listed)
- presence of glaucoma,
- diabetic retinopathy,
- retinal vascular disease,
- high myopia (defined as AL > 25mm),
- uveitis,
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 |
|---|---|---|
| phacoemulsifcationAlso: high aspiration flow rate,, high vacuumA sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit | Device | 1. High fluidic parameters |
| phacoemulsifcationAlso: low flow rate, low vacuum, low bottle heightA sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit | Device | 2. Low fluidic parameters |
Primary outcome
IOP fluctuation during each phase of surgery
Time frame: intra-operative
1 secondary outcome
comparison of IOP fluctuations between high and low parameters group
Time frame: intra-operative
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 5 Mar 2009.
- Background: PubMed 12757089Grinbaum A, Blumenthal M, Assia E. Comparison of intraocular pressure profiles during cataract surgery by phacoemulsification and extracapsular cataract extraction. Ophthalmic Surg Lasers Imaging. 2003 May-Jun;34(3):182-6.
- Background: PubMed 17222793Georgescu D, Payne M, Olson RJ. Objective measurement of postocclusion surge during phacoemulsification in human eye-bank eyes. Am J Ophthalmol. 2007 Mar;143(3):437-40. doi: 10.1016/j.ajo.2006.11.017. Epub 2006 Dec 18.
- Background: PubMed 16565009Khng C, Packer M, Fine IH, Hoffman RS, Moreira FB. Intraocular pressure during phacoemulsification. J Cataract Refract Surg. 2006 Feb;32(2):301-8. doi: 10.1016/j.jcrs.2005.08.062.
- Background: PubMed 16286613Moorhead LC, Gardner TW, Lambert HM, O'Malley RE, Willis AW, Meharg LS, Moorhead WD. Dynamic intraocular pressure measurements during vitrectomy. Arch Ophthalmol. 2005 Nov;123(11):1514-23. doi: 10.1001/archopht.123.11.1514.
- Background: PubMed 10209431Joos KM, Kay MD, Pillunat LE, Harris A, Gendron EK, Feuer WJ, Steinwand BE. Effect of acute intraocular pressure changes on short posterior ciliary artery haemodynamics. Br J Ophthalmol. 1999 Jan;83(1):33-8. doi: 10.1136/bjo.83.1.33.
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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.
Abhay R Vasavada, FRCS principal investigator
Iladevi Cataract and IOL Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsifcation in people with Intraocular Pressure, run by Iladevi Cataract and IOL Research Center at 1 site in India.
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 2 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 5 Mar 2009. 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 India. 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?
IOP fluctuation during each phase of surgery (time frame: intra-operative). 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 NCT00856141, which also lists 5 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 5 Mar 2009.