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| Name | Class |
|---|---|
| Ministry of Health, China | OTHER_GOV |
| National Natural Science Foundation of China | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | 1.8-mm-incision-size phacoemulsification system |
| |
| Group II | 2.2-mm-incision-size phacoemulsification system |
| |
| Group III | 3.0-mm-incision-size phacoemulsification system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phacoemulsification | Procedure | Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, M.D.,Ph.D. | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen U | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16436926 | Background | 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. | |
| 20494758 | Background | 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. |
| Label | URL |
|---|---|
| Home page of our investigation ophthalmic center | View source |
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Potential subjects with previous intraocular surgery, glaucoma, pseudoexfoliation, uveitis, high myopia and diabetes mellitus were excluded from participation in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I | 1.8-mm-incision-size phacoemulsification system |
| FG001 | Group II | 2.2-mm-incision-size phacoemulsification system |
| FG002 | Group III | 3.0-mm-incision-size phacoemulsification system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I | 1.8-mm-incision-size phacoemulsification system |
| BG001 | Group II | 2.2-mm-incision-size phacoemulsification system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Central Cornea Endothelial Cell Loss | Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density. | 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. | Posted | Mean | Standard Deviation | % of endothelial cell loss | post-operative week 1, post-operative month 1, and post-operative month 3 |
|
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Total Number of Participants at Risk for this Observational Study (e.g., serious and/or other [non-serious] adverse events were not collected/assessed).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I | 1.8-mm-incision-size phacoemulsification system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Yizhi Liu | SunYat-senU | +86-20-87330341 | Reviewborad_SYsU@163.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 19251139 | Background | 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. |
| 18939349 | Result | 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. |
| 17276271 | Result | 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. |
| 18567650 | Result | 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. |
| 19878827 | Result | 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. |
| 19548882 | Result | 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. |
| 22310081 | Derived | 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. |
| BG002 | Group III | 3.0-mm-incision-size phacoemulsification system |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
2.2-mm-incision-size phacoemulsification system
| OG002 | Group III | 3.0-mm-incision-size phacoemulsification system |
|
|
| 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. | The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis. | Posted | Mean | Standard Deviation | logMAR | post-operative week 1, post-operative month 1, and post-operative month 3 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Diopters | post-operative week 1, post-operative month 1, and post-operative month 3 |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group II | 2.2-mm-incision-size phacoemulsification system | 0 | 0 | 0 | 0 |
| EG002 | Group III | 3.0-mm-incision-size phacoemulsification system | 0 | 0 | 0 | 0 |
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| D059708 | Ultrasonic Surgical Procedures |
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| Post-op 1 month |
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| Post-op 3 months |
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| Post-op 1 month |
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| Post-op 3 months |
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