Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification
Study Details
Study Description
Brief Summary
In this study, the investigators introduce a new "capsule-reserved" cataract surgical procedure in which anterior lens capsule is reserved and attached onto posterior lens capsule in the purpose of preventing posterior capsule opacification (PCO). A prospective randomized controlled study is reported to compare the new "capsule-reserved" surgical procedure with conventional one on the effectiveness to prevent posterior capsule opacification in age-related cataract patients.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
A prospective, randomized controlled study of 240 eligible patients will been enrolled. Two eyes of each patient were assigned randomly to two groups respectively: Group I; anterior lens capsule is conventionally not reserved after continuous curvilinear capsulorhexis, while in Group II, anterior lens capsule is innovatively reserved and attached onto posterior lens capsule. This novel adjusted surgical procedure, featured by using the reserved anterior lens capsule to protect the peri-capsule microenvironment and prevent PCO, is conceptual different from the traditional cataract surgical procedure. Clinical examinations including posterior capsule opacification grading score, central posterior capsule thickness, central posterior capsule density, best corrected visual acuity, contrast sensitivity were carried out preoperatively and at each postoperative visit.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Capsule-reserved surgical procedure In this group, the anterior lens capsule was reserved after continuous curvilinear capsulorhexis. The reserved anterior capsule was pressed flattened by the optical surface of the IOL and attached onto the posterior lens capsule. Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. |
Procedure: Anterior lens capsule was reserved
The anterior lens capsule was reserved after continuous curvilinear capsulorhexis. The reserved anterior capsule was pressed flattened by the optical surface of the IOL and attached onto the posterior lens capsule.
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No Intervention: Conventional surgical procedure In this group, the anterior lens capsule was not reserved or attached onto the posterior lens capsule. |
Outcome Measures
Primary Outcome Measures
- Change from Baseline in posterior capsule opacification grading score [post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3,]
Posterior capsule opacification(PCO)was recorded by standardized slit lamp retroillumination images and analyzed using the EPCO2000 program. The severity of PCO was clinically graded from 0 (none) to 4 (severe)
Secondary Outcome Measures
- Change from Baseline in central posterior capsule thickness [post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1]
Central posterior capsule thickness was recorded and calculated by Pentacam HR system
- Change from Baseline in central posterior capsule density [post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1]
Central posterior capsule density was recorded and calculated by Pentacam HR system.
Other Outcome Measures
- Change from Baseline in best corrected visual acuity [post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1]
Best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist.
- Change from Baseline in contrast sensitivity [post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1]
Contrast sensitivity under mesopic and photopic conditions was measured using C-quant
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 50 years or above
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Both eyes were diagnosed with age-related cataract
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Both eyes were planed to undergo the "Phacoemulsification and IOL implantation" surgery with 1 month
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Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists.
Exclusion Criteria:
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Other ocular diseases
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ACD<3CT
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Combined cataract surgery (trabeculoplasty, keratoplasty)
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Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities
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Previous intraocular surgery or trauma (laser not included)
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Uveitis
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Recent ocular infection
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Proliferative diabetic retinopathy
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Diabetes mellitus
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Congenital ocular abnormalities (aniridia, congenital cataract)
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Atrophy of iris
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Participants with previous clinical trials 30 days before surgery
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Using prostanoid eye drops
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Uncontrolled systematic diseases
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Zhognshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Yizhi Liu, M.D., PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Lin H, Yan P, Yu K, Luo L, Chen J, Lin Z, Chen W. Anterior segment variations after posterior chamber phakic intraocular lens implantation in myopic eyes. J Cataract Refract Surg. 2013 May;39(5):730-8. doi: 10.1016/j.jcrs.2012.12.026. Epub 2013 Mar 14.
- Lin HT, Chen WR, Ding ZF, Chen W, Wu CR. Clinical evaluation of two multifocal intraocular lens implantation patterns. Int J Ophthalmol. 2012;5(1):76-83. doi: 10.3980/j.issn.2222-3959.2012.01.16. Epub 2012 Feb 18.
- Luo L, Lin H, Chen W, Qu B, Zhang X, Lin Z, Chen J, Liu Y. Intraocular lens-shell technique: adjustment of the surgical procedure leads to greater safety when treating dense nuclear cataracts. PLoS One. 2014 Nov 17;9(11):e112663. doi: 10.1371/journal.pone.0112663. eCollection 2014.
- 2015MEKY046