Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01429532
• Collaborator: Ministry of Health, China (Other), National Natural Science Foundation of China (Other)
• Enrollment: 120
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 12

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: phacoemulsification

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Clinical Evaluation of Three Incision-size-dependent Phacoemulsification Systems
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: Three incision-size(1.8, 2.2 and 3.0 mm)

Outcome Measures

Primary Outcome Measures

1. Central Cornea Endothelial Cell Loss [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 [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 Outcome Measures

1. Best-corrected Visual Acuity [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Home page of our investigation ophthalmic center

Publications

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

• Responsible Party: Haotian Lin, Department of cataract, Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01429532
• Other Study ID Numbers: CCPMOH2010-China2
• First Posted: Sep 7, 2011
• Last Update Posted: Jul 11, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Haotian Lin, Department of cataract, Zhongshan Ophthalmic Center, Sun Yat-sen University: Cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	This prospective randomized study included 120 patients (120 eyes) with age-related cataract enrolled between July 2010 and January 2011 at the Zhong-shan Ophthalmic Center, Guangzhou, China.
Pre-assignment Detail	Potential subjects with previous intraocular surgery, glaucoma, pseudoexfoliation, uveitis, high myopia and diabetes mellitus were excluded from participation in the study.

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	1.8-mm-incision-size phacoemulsification system	2.2-mm-incision-size phacoemulsification system	3.0-mm-incision-size phacoemulsification system
Period Title: Overall Study
STARTED	40	40	40
COMPLETED	40	40	40
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Group I	Group II	Group III	Total
Arm/Group Description	1.8-mm-incision-size phacoemulsification system	2.2-mm-incision-size phacoemulsification system	3.0-mm-incision-size phacoemulsification system	Total of all reporting groups
Overall Participants	40	40	40	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 30%	12 30%	12 30%	36 30%
>=65 years	28 70%	28 70%	28 70%	84 70%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.95 (6.05)	71.37 (7.19)	72.48 (6.15)	72.59 (6.32)
Sex: Female, Male (Count of Participants)
Female	19 47.5%	22 55%	21 52.5%	62 51.7%
Male	21 52.5%	18 45%	19 47.5%	58 48.3%
Region of Enrollment (participants) [Number]
China	40 100%	40 100%	40 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Central Cornea Endothelial Cell Loss
Description	Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Time Frame	post-operative week 1, post-operative month 1, and post-operative month 3

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	1.8-mm-incision-size phacoemulsification system	2.2-mm-incision-size phacoemulsification system	3.0-mm-incision-size phacoemulsification system
Measure Participants	40	40	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)

2. Secondary Outcome

Title	Best-corrected Visual Acuity
Description	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.
Time Frame	post-operative week 1, post-operative month 1, and post-operative month 3

Outcome Measure Data

Analysis Population Description

The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	1.8-mm-incision-size phacoemulsification system	2.2-mm-incision-size phacoemulsification system	3.0-mm-incision-size phacoemulsification system
Measure Participants	40	40	40
Pre-op 1 day	0.16 (0.10)	0.13 (0.11)	0.15 (0.11)
Post-op 1 day	0.66 (0.27)	0.71 (0.20)	0.73 (0.23)
Post-op 1 month	0.89 (0.20)	0.91 (0.13)	0.88 (0.14)
Post-op 3 months	0.98 (0.11)	1.01 (0.09)	0.98 (0.10)

3. Primary Outcome

Title	Surgically Induced Astigmatism
Description	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.
Time Frame	post-operative week 1, post-operative month 1, and post-operative month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I	Group II	Group III
Arm/Group Description	1.8-mm-incision-size phacoemulsification system	2.2-mm-incision-size phacoemulsification system	3.0-mm-incision-size phacoemulsification system
Measure Participants	40	40	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)

Adverse Events

Adverse Event Reporting Description	Total Number of Participants at Risk for this Observational Study (e.g., serious and/or other [non-serious] adverse events were not collected/assessed).
Arm/Group Title	Group I		Group II		Group III
Arm/Group Description	1.8-mm-incision-size phacoemulsification system		2.2-mm-incision-size phacoemulsification system		3.0-mm-incision-size phacoemulsification system
All Cause Mortality
	Group I		Group II		Group III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group I		Group II		Group III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Group I		Group II		Group III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.