NCT01429532

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 11, 2014

Completed
Last Updated

July 11, 2014

Status Verified

June 1, 2014

Enrollment Period

10 months

First QC Date

September 4, 2011

Results QC Date

December 25, 2012

Last Update Submit

June 6, 2014

Conditions

Cataract

Keywords

Cataract

Outcome Measures

Primary Outcomes (2)

  • Central Cornea Endothelial Cell Loss

    Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.

    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.

    post-operative week 1, post-operative month 1, and post-operative month 3

Secondary Outcomes (1)

  • Best-corrected Visual Acuity

    post-operative week 1, post-operative month 1, and post-operative month 3

Study Arms (3)

Group I

1.8-mm-incision-size phacoemulsification system

Procedure: phacoemulsification

Group II

2.2-mm-incision-size phacoemulsification system

Procedure: phacoemulsification

Group III

3.0-mm-incision-size phacoemulsification system

Procedure: phacoemulsification

Interventions

phacoemulsificationPROCEDURE

Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)

Also known as: Three incision-size(1.8, 2.2 and 3.0 mm)
Group IGroup IIGroup III

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • previous intraocular surgery
  • glaucoma
  • pseudoexfoliation
  • uveitis
  • high myopia
  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen U

Guangzhou, Guangdong, 510060, China

Location

Related Publications (9)

  • 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.

    PMID: 16436926BACKGROUND

  • 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.

    PMID: 20494758BACKGROUND

  • 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.

    PMID: 19251139BACKGROUND

  • 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.

    PMID: 18939349RESULT

  • 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.

    PMID: 17276271RESULT

  • 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.

    PMID: 18567650RESULT

  • 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.

    PMID: 19878827RESULT

  • 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.

    PMID: 19548882RESULT

  • 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.

    PMID: 22310081DERIVED

Related Links

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Results Point of Contact

Title
Prof. Yizhi Liu
Organization
SunYat-senU
Reviewborad_SYsU@163.com
+86-20-87330341

Study Officials

  • Yizhi Liu, M.D.,Ph.D.

    Sun Yat-sen University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of cataract, Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

September 4, 2011

First Posted

September 7, 2011

Study Start

July 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 11, 2014

Results First Posted

July 11, 2014

Record last verified: 2014-06

Locations

CN(1)