Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, China
National Natural Science Foundation of China
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01429532
First received: September 4, 2011
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Cataract
Procedure: phacoemulsification

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Central Cornea Endothelial Cell Loss [ Time Frame: post-operative week 1, post-operative month 1, and post-operative month 3 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Best-corrected Visual Acuity [ Time Frame: post-operative week 1, post-operative month 1, and post-operative month 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group I
1.8-mm-incision-size phacoemulsification system
Procedure: phacoemulsification
Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)
Other Name: Three incision-size(1.8, 2.2 and 3.0 mm)
Group II
2.2-mm-incision-size phacoemulsification system
Procedure: phacoemulsification
Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)
Other Name: Three incision-size(1.8, 2.2 and 3.0 mm)
Group III
3.0-mm-incision-size phacoemulsification system
Procedure: phacoemulsification
Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)
Other Name: Three incision-size(1.8, 2.2 and 3.0 mm)

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • previous intraocular surgery
  • glaucoma
  • pseudoexfoliation
  • uveitis
  • high myopia
  • diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429532

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen U
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
National Natural Science Foundation of China
Investigators
Study Director: Yizhi Liu, M.D.,Ph.D. Sun Yat-sen University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haotian Lin, Department of cataract, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01429532     History of Changes
Other Study ID Numbers: CCPMOH2010-China2
Study First Received: September 4, 2011
Results First Received: December 25, 2012
Last Updated: June 6, 2014
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Cataract

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 23, 2014