Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm). Read more about this study

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Cataract
What is being tested?: phacoemulsification
Type of treatment: Surgery or procedure
How many people: 120 participants
Where: 1 siteChina
Study dates: Jul 2010to May 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: This prospective randomized study comprised 120 patients (120 eyes) with age-related cataract enrolled for surgeries between July 2010 and January 2011 at the Zhongshan Ophthalmic Center, Guangzhou, China.

Who may be able to join

age between 55 and 85 years
the presence of nuclear or cortex-nuclear cataract, grades 2.0 to 4.0 (Lens Opacities Classification System III)
a transparent central cornea
pupil dilating to >= 7 mm at the time of preoperative examination
a preoperative central endothelial cell count of >= 1500 cells per square millimeter

Who cannot join

previous intraocular surgery
glaucoma
pseudoexfoliation
uveitis
high myopia
diabetes mellitus

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Ophthalmic Center, Sun Yat-sen U
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems

The purpose of this study is to compare the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).

Read the detailed description

It is generally the case that smaller corneal cataract surgical incisions are associated with more rapid wound healing, more stable corneal biomechanical properties and less surgically induced astigmatism (SIA). With the development of phacoemulsification and foldable intraocular lenses (IOL) during recent decades, the size of clear corneal incisions has been reduced from 3.2-mm (coaxial small incision) to 1.4-mm (bimanual micro incision). Micro incision cataract surgery (MICS), including bimanual and micro coaxial phacoemulsification, has attracted much interest recently, due to its safety and ease of learning. However, the superiority of coaxial micro incision cataract surgery as compared conventional coaxial cataract surgery is still not certain, because micro incision phacoemulsification may result in longer ultrasound time (UST), the use of more ultrasonic power and consequently higher endothelial cell loss (ECL).

In our previous studies of the OZil Torsional phacoemulsification system (Infinity, Alcon), we reported that the safety and effectiveness of cataract surgery are influenced by many factors, including the blade used to create the incision, the phacoemulsification apparatus, and the IOL and mode of IOL delivery, which together constitute a surgical system, whose outcomes are restricted by the best performance of each component. Today, micro coaxial phacoemulsification is in wide use for cataract surgery, but the lower limits of incision size should be understood in the context of the various components of the surgical system.

In this study, we compared the safety and efficacy of three different incision-size-dependent phacoemulsification systems, 1.8, 2.2 and 3.0 mm, and evaluated the relationship between incision size and SIA.

Conditions: Cataract
Being tested: phacoemulsification
Keywords: Cataract
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

phacoemulsificationProcedure or surgery
Also called Three incision-size(1.8, 2.2 and 3.0 mm)
Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)

Study groups in NCT01429532
Study group	Role	What they receive
Group I		1.8-mm-incision-size phacoemulsification system Receives: Procedure: phacoemulsification
Group II		2.2-mm-incision-size phacoemulsification system Receives: Procedure: phacoemulsification
Group III		3.0-mm-incision-size phacoemulsification system Receives: Procedure: phacoemulsification

What is being measured

The primary outcome is the main question the study is designed to answer.

Central Cornea Endothelial Cell Loss
Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Measured: post-operative week 1, post-operative month 1, and post-operative month 3
Surgically Induced Astigmatism
Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.
Measured: post-operative week 1, post-operative month 1, and post-operative month 3

Secondary outcomes (1)

Best-corrected Visual Acuity
The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months.
Measured: post-operative week 1, post-operative month 1, and post-operative month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010May 2011

First posted7 Sep 2011 (estimated)
Study startJul 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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: Case-control
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01429532
Sponsor's protocol ID: CCPMOH2010-China2
Status last verified: Jun 2014
First submitted: 4 Sep 2011
Last updated: 11 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Weikert MP. Update on bimanual microincisional cataract surgery. Curr Opin Ophthalmol. 2006 Feb;17(1):62-7. doi: 10.1097/01.icu.0000193069.32369.e1.
PubMed 16436926
Alio JL, Agdeppa MC, Rodriguez-Prats JL, Amparo F, Pinero DP. Factors influencing corneal biomechanical changes after microincision cataract surgery and standard coaxial phacoemulsification. J Cataract Refract Surg. 2010 Jun;36(6):890-7. doi: 10.1016/j.jcrs.2009.12.041.
PubMed 20494758
Elkady B, Pinero D, Alio JL. Corneal incision quality: microincision cataract surgery versus microcoaxial phacoemulsification. J Cataract Refract Surg. 2009 Mar;35(3):466-74. doi: 10.1016/j.jcrs.2008.11.047.
PubMed 19251139
Liu Y, Jiang Y, Wu M, Liu Y, Zhang T. Bimanual microincision phacoemulsification in treating hard cataracts using different power modes. Clin Exp Ophthalmol. 2008 Jul;36(5):426-30.
PubMed 18939349
Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
PubMed 17276271
Zeng M, Liu X, Liu Y, Xia Y, Luo L, Yuan Z, Zeng Y, Liu Y. Torsional ultrasound modality for hard nucleus phacoemulsification cataract extraction. Br J Ophthalmol. 2008 Aug;92(8):1092-6. doi: 10.1136/bjo.2007.128504. Epub 2008 Jun 20.
PubMed 18567650
Wang Y, Xia Y, Zeng M, Liu X, Luo L, Chen B, Liu Y, Liu Y. Torsional ultrasound efficiency under different vacuum levels in different degrees of nuclear cataract. J Cataract Refract Surg. 2009 Nov;35(11):1941-5. doi: 10.1016/j.jcrs.2009.05.055.
PubMed 19878827
Xia Y, Liu X, Luo L, Zeng Y, Cai X, Zeng M, Liu Y. Early changes in clear cornea incision after phacoemulsification: an anterior segment optical coherence tomography study. Acta Ophthalmol. 2009 Nov;87(7):764-8. doi: 10.1111/j.1755-3768.2008.01333.x. Epub 2009 Jun 22.
PubMed 19548882
Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
PubMed 22310081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems
ClinicalTrials.gov ID: NCT01429532
Acronym / sponsor ID: CCPMOH2010-China2
Conditions: Cataract
Keywords: Cataract
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: Ministry of Health, China, National Natural Science Foundation of China
Study start: Jul 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 7 Sep 2011 (estimated)
Results: Posted 11 Jul 2014

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 the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Group I	–	Procedure: phacoemulsification1.8-mm-incision-size phacoemulsification system
Group II	–	Procedure: phacoemulsification2.2-mm-incision-size phacoemulsification system
Group III	–	Procedure: phacoemulsification3.0-mm-incision-size phacoemulsification system

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This prospective randomized study comprised 120 patients (120 eyes) with age-related cataract enrolled for surgeries between July 2010 and January 2011 at the Zhongshan Ophthalmic Center, Guangzhou, China.

Key inclusion criteria (5 listed)

age between 55 and 85 years
the presence of nuclear or cortex-nuclear cataract, grades 2.0 to 4.0 (Lens Opacities Classification System III)
a transparent central cornea
pupil dilating to >= 7 mm at the time of preoperative examination
a preoperative central endothelial cell count of >= 1500 cells per square millimeter

Key exclusion criteria (6 listed)

previous intraocular surgery
glaucoma
pseudoexfoliation
uveitis
high myopia

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
phacoemulsificationAlso: Three incision-size(1.8, 2.2 and 3.0 mm)Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)	Procedure or surgery	Group I, Group II, Group III

Primary outcome

Central Cornea Endothelial Cell Loss
Time frame: post-operative week 1, post-operative month 1, and post-operative month 3
Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Surgically Induced Astigmatism
Time frame: post-operative week 1, post-operative month 1, and post-operative month 3
Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.

1 secondary outcome

Best-corrected Visual Acuity
Time frame: post-operative week 1, post-operative month 1, and post-operative month 3

Results and safety

Results posted to the registry on 11 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I	40	40
Group II	40	40
Group III	40	40

Primary outcome: Central Cornea Endothelial Cell Loss

Time frame: post-operative week 1, post-operative month 1, and post-operative month 3. Mean (Standard Deviation). Unit: % of endothelial cell loss

Measure	Group I n = 40	Group II n = 40	Group III n = 40
Post-op 1m	11.78 (7.27)	13.03 (8.33)	12.05 (9.31)
Post-op 1 w	7.77 (3.76)	9.35 (4.69)	7.93 (3.67)
Post-op 3 month	17.83 (5.65)	18.08 (7.93)	17.66 (5.26)

Population analysed: The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis and sample size calculation. Mean ultrasound time (UST), surgical time, cumulative dissipated energy (CDE), total BSS volume, and SIA were compared using multifactor analysis of variance.

Primary outcome: Surgically Induced Astigmatism

Time frame: post-operative week 1, post-operative month 1, and post-operative month 3. Mean (Standard Deviation). Unit: Diopters

Measure	Group I n = 40	Group II n = 40	Group III n = 40
Post-op 1 day	1.2 (0.32)	0.91 (0.34)	0.951 (0.28)
Post-op 1 week	0.61 (0.24)	0.74 (0.25)	0.79 (0.23)
Post-op 1 month	0.4 (0.21)	0.46 (0.24)	0.75 (0.31)
Post-op 3 months	0.26 (0.18)	0.31 (0.19)	0.66 (0.21)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I	0 of 0	0 of 0	Not reported
Group II	0 of 0	0 of 0	Not reported
Group III	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16436926Weikert MP. Update on bimanual microincisional cataract surgery. Curr Opin Ophthalmol. 2006 Feb;17(1):62-7. doi: 10.1097/01.icu.0000193069.32369.e1.
Background: PubMed 20494758Alio JL, Agdeppa MC, Rodriguez-Prats JL, Amparo F, Pinero DP. Factors influencing corneal biomechanical changes after microincision cataract surgery and standard coaxial phacoemulsification. J Cataract Refract Surg. 2010 Jun;36(6):890-7. doi: 10.1016/j.jcrs.2009.12.041.
Background: PubMed 19251139Elkady B, Pinero D, Alio JL. Corneal incision quality: microincision cataract surgery versus microcoaxial phacoemulsification. J Cataract Refract Surg. 2009 Mar;35(3):466-74. doi: 10.1016/j.jcrs.2008.11.047.
Results publication: PubMed 18939349Liu Y, Jiang Y, Wu M, Liu Y, Zhang T. Bimanual microincision phacoemulsification in treating hard cataracts using different power modes. Clin Exp Ophthalmol. 2008 Jul;36(5):426-30.
Results publication: PubMed 17276271Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
Results publication: PubMed 18567650Zeng M, Liu X, Liu Y, Xia Y, Luo L, Yuan Z, Zeng Y, Liu Y. Torsional ultrasound modality for hard nucleus phacoemulsification cataract extraction. Br J Ophthalmol. 2008 Aug;92(8):1092-6. doi: 10.1136/bjo.2007.128504. Epub 2008 Jun 20.
Results publication: PubMed 19878827Wang Y, Xia Y, Zeng M, Liu X, Luo L, Chen B, Liu Y, Liu Y. Torsional ultrasound efficiency under different vacuum levels in different degrees of nuclear cataract. J Cataract Refract Surg. 2009 Nov;35(11):1941-5. doi: 10.1016/j.jcrs.2009.05.055.
Results publication: PubMed 19548882Xia Y, Liu X, Luo L, Zeng Y, Cai X, Zeng M, Liu Y. Early changes in clear cornea incision after phacoemulsification: an anterior segment optical coherence tomography study. Acta Ophthalmol. 2009 Nov;87(7):764-8. doi: 10.1111/j.1755-3768.2008.01333.x. Epub 2009 Jun 22.
Derived from this study: PubMed 22310081Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
Home page of our investigation ophthalmic centerLink 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.

Yizhi Liu, M.D.,Ph.D. study director

Sun Yat-sen University

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 Cataract, run by Sun Yat-sen University at 1 site in China.

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 5 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 11 Jul 2014. 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 China. 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?

Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Central Cornea Endothelial Cell Loss (time frame: post-operative week 1, post-operative month 1, and post-operative month 3). 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 NCT01429532, which also lists 9 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 11 Jul 2014.