Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

Cataract Clinical Trial

Official title:

Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429532
• Other study ID #: CCPMOH2010-China2
• Status: Completed
• Phase: N/A
• First received: September 4, 2011
• Last updated: June 6, 2014
• Start date: July 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen U	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (8)

Alió JL, Agdeppa MC, Rodríguez-Prats JL, Amparo F, Piñero 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. — View Citation

Elkady B, Piñero D, Alió 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. — View Citation

Liu Y, Jiang Y, Wu M, Liu Y, Zhang T. Bimanual microincision phacoemulsification in treating hard cataracts using different power modes. Clin Experiment Ophthalmol. 2008 Jul;36(5):426-30. — View Citation

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. — View Citation

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. — View Citation

Weikert MP. Update on bimanual microincisional cataract surgery. Curr Opin Ophthalmol. 2006 Feb;17(1):62-7. Review. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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.	post-operative week 1, post-operative month 1, and post-operative month 3	No

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