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Completed

NCT Number: NCT01429532

Outcomes of 3 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).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen U

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification

Procedure

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

Other names: Three incision-size(1.8, 2.2 and 3.0 mm)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Best-corrected Visual Acuity

    Time frame: post-operative week 1, post-operative month 1, and post-operative month 3

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Ministry of Health, China
  • National Natural Science Foundation of China

Registry information

Official study title

Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 7, 2011
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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