CataractNCT00370955
The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
A study testing phacoemulsification using either high vacuum or low vacuum techniques in people with Cataract, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to compare two surgical techniques (high vacuum and low vacuum) on corneal endothelium after phacoemulsification. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Cataract
- What is being tested?
- phacoemulsification using either high vacuum or low vacuum techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Mar 2007to Dec 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate lens opacity (Nuclear sclerosis 3+)
- Age between 50 to 70 years
- The exclusion criteria were:
- Previous corneal pathology (dystrophic or degenerative such as Fuchs' endothelial dystrophy or advanced trachoma),
- Pseudoexfoliation syndrome (PEX),
- History of intra ocular surgery,
Show all 19Show fewer
- Glaucoma or ocular hypertension,
- Eyes with a history of anterior uveitis,
- Diabetes mellitus,
- Anterior chamber depth (ACD) less than 2.5 mm or more than 4 mm,
- Axial length less than 21 mm or more than 25 mm,
- Density of endothelial cells less than 1500 cells per mm2,
- Polymegatism (CV > 0.4),
- Keratometric astigmatism more than 1.5 Diopters (D),
- History of contact lens usage,
- Intra-operative complications (posterior capsule rupture with or without vitreous loss),
- Postoperative uveitis,
- Postoperative surgical wound leakage,
- Deep-set eye, and 17- size of dilated pupil less than 6 mm.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare two surgical techniques (high vacuum and low vacuum) on corneal endothelium after phacoemulsification.
Read the detailed description
Patients aged 50 to 70 years old with moderate lens opacities (nuclear sclerosis of 3+) were included. The exclusion criteria were: 1-previous corneal pathology (dystrophic or degenerative such as Fuchs' endothelial dystrophy or advanced trachoma), 2- pseudoexfoliation syndrome (PEX), 3- history of intra ocular surgery, 4- glaucoma or ocular hypertension, 5- eyes with a history of anterior uveitis, 6- diabetes mellitus, 7- anterior chamber depth (ACD) less than 2.5 mm or more than 4 mm, 8- axial length less than 21 mm or more than 25 mm, 9- density of endothelial cells less than 1500 cells per mm2, 10- polymegatism (CV > 0.4), 11- keratometric astigmatism more than 1.5 Diopters (D), 12- history of contact lens usage, 13- Intra-operative complications (posterior capsule rupture with or without vitreous loss), 14- postoperative uveitis, 15- postoperative surgical wound leakage, 16- deep-set eye, and 17- size of dilated pupil less than 6 mm. Nucleus density was evaluated using the LOCS III classification system Patients were divided in 2 groups randomly: Group 1 included those candidates for phacoemulsification using high hydrodynamic parameter: 400 mmHg vacuum and 40 ml/min flow rate (high vacuum technique) whereas group 2 consisted of patients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min flow rate (low vacuum technique). All surgeries were performed by one surgeon using stop and chop technique with sovereign (white star technology) (AMO, USA). During sculpting stage, vacuum was 40mmHg and flow rate is 20ml/min, in both groups. Irrigation aspiration of cortical material and viscoelastic were bimanually and semi automatically performed with flow rate of 30ml/min.
Total ultrasound power and total volume of BSS in both groups were measured. Pachymetry, endothelial cell density, polymegathism, before and 1, 6 and 12 weeks after intervention were also evaluated. Statistically analysis of data included univariate (student t-test and x2) and multivariate (regression model) analysis of postoperative results.
- Conditions
- Cataract
- Being tested
- phacoemulsification using either high vacuum or low vacuum techniques
- Keywords
- Phacoemulsification, Corneal endothelial cell loss, Hydrodynamic parameters, Total ultrasound energy, Total infused fluids
- Medical subject headings
- Cataract, Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification using either high vacuum or low vacuum techniquesProcedure or surgery
Also called stop and chop technique
All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.
| Study group | Role | What they receive |
|---|---|---|
| High vacuum group | Active comparator | Those patients who underwent phacoemulsification using high hydrodynamic parameter: 400 mmHg vacuum and 40 ml/min flow rate. Receives: Procedure: phacoemulsification using either high vacuum or low vacuum techniques |
| Low vacuum group | Active comparator | Patients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min flow rate. Receives: Procedure: phacoemulsification using either high vacuum or low vacuum techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ultrasound energy dissipated to the eye, total infused fluid, Endothelial cell loss
Measured: All patients were examined on postoperative day 1 and weeks 1, 6 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startMar 2007
- Primary completionAug 2007
- Study completionDec 2007
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Alireza Baradaran Raffiee, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370955
- Sponsor's protocol ID
- 8527
- Status last verified
- Oct 2008
- First submitted
- 31 Aug 2006
- Last updated
- 25 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
- ClinicalTrials.gov ID
- NCT00370955
- Acronym / sponsor ID
- 8527
- Conditions
- Cataract
- Keywords
- Phacoemulsification, Corneal endothelial cell loss, Hydrodynamic parameters, Total ultrasound energy, Total infused fluids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Sep 2006 (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.
The purpose of this study is to compare two surgical techniques (high vacuum and low vacuum) on corneal endothelium after phacoemulsification.
Detailed description
Patients aged 50 to 70 years old with moderate lens opacities (nuclear sclerosis of 3+) were included. The exclusion criteria were: 1-previous corneal pathology (dystrophic or degenerative such as Fuchs' endothelial dystrophy or advanced trachoma), 2- pseudoexfoliation syndrome (PEX), 3- history of intra ocular surgery, 4- glaucoma or ocular hypertension, 5- eyes with a history of anterior uveitis, 6- diabetes mellitus, 7- anterior chamber depth (ACD) less than 2.5 mm or more than 4 mm, 8- axial length less than 21 mm or more than 25 mm, 9- density of endothelial cells less than 1500 cells per mm2, 10- polymegatism (CV > 0.4), 11- keratometric astigmatism more than 1.5 Diopters (D), 12- history of contact lens usage, 13- Intra-operative complications (posterior capsule rupture with or without vitreous loss), 14- postoperative uveitis, 15- postoperative surgical wound leakage, 16- deep-set eye, and 17- size of dilated pupil less than 6 mm. Nucleus density was evaluated using the LOCS III classification system Patients were divided in 2 groups randomly: Group 1 included those candidates for phacoemulsification using high hydrodynamic parameter: 400 mmHg vacuum and 40 ml/min flow rate (high vacuum technique) whereas group 2 consisted of patients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min flow rate (low vacuum technique). All surgeries were performed by one surgeon using stop and chop technique with sovereign (white star technology) (AMO, USA). During sculpting stage, vacuum was 40mmHg and flow rate is 20ml/min, in both groups. Irrigation aspiration of cortical material and viscoelastic were bimanually and semi automatically performed with flow rate of 30ml/min.
Total ultrasound power and total volume of BSS in both groups were measured. Pachymetry, endothelial cell density, polymegathism, before and 1, 6 and 12 weeks after intervention were also evaluated. Statistically analysis of data included univariate (student t-test and x2) and multivariate (regression model) analysis of postoperative results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High vacuum group | Active comparator | Procedure: phacoemulsification using either high vacuum or low vacuum techniquesThose patients who underwent phacoemulsification using high hydrodynamic parameter: 400 mmHg vacuum and 40 ml/min flow rate. |
| Low vacuum group | Active comparator | Procedure: phacoemulsification using either high vacuum or low vacuum techniquesPatients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min flow rate. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Moderate lens opacity (Nuclear sclerosis 3+)
- Age between 50 to 70 years
- Previous corneal pathology (dystrophic or degenerative such as Fuchs' endothelial dystrophy or advanced trachoma),
- Pseudoexfoliation syndrome (PEX),
- History of intra ocular surgery,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| phacoemulsification using either high vacuum or low vacuum techniquesAlso: stop and chop techniqueAll surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology. | Procedure or surgery | High vacuum group, Low vacuum group |
Primary outcome
Total ultrasound energy dissipated to the eye, total infused fluid, Endothelial cell loss
Time frame: All patients were examined on postoperative day 1 and weeks 1, 6 and 12.
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 25 Dec 2009.
- Published articleLink provided by the sponsor.
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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.
Alireza Baradaran Raffiee, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification using either high vacuum or low vacuum techniques in people with Cataract, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 19 inclusion and 0 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 25 Dec 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 Iran. 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?
Total ultrasound energy dissipated to the eye, total infused fluid, Endothelial cell loss (time frame: All patients were examined on postoperative day 1 and weeks 1, 6 and 12.). 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 25 Dec 2009.