Clinical trial NCT02445274: Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification
Official title: Effectiveness of Two Different Surgical Procedures to Prevent Posterior Capsule Opacification in Age-related Cataract Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Posterior Capsule Opacification
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 50 years or above
2. Both eyes were diagnosed with age-related cataract
3. Both eyes were planed to undergo the "Phacoemulsification and IOL implantation" surgery with 1 month
4. Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists.

Exclusion Criteria:

1. Other ocular diseases
2. ACD\<3CT
3. Combined cataract surgery (trabeculoplasty, keratoplasty)
4. Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities
5. Previous intraocular surgery or trauma (laser not included)
6. Uveitis
7. Recent ocular infection
8. Proliferative diabetic retinopathy
9. Diabetes mellitus
10. Congenital ocular abnormalities (aniridia, congenital cataract)
11. Atrophy of iris
12. Participants with previous clinical trials 30 days before surgery
13. Using prostanoid eye drops
14. Uncontrolled systematic diseases

Primary outcomes:
measure: Change from Baseline in posterior capsule opacification grading score
timeFrame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3,
Secondary outcomes:
measure: Change from Baseline in central posterior capsule thickness
timeFrame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1
measure: Change from Baseline in central posterior capsule density
timeFrame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1
Other outcomes:
measure: Change from Baseline in best corrected visual acuity
timeFrame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1
measure: Change from Baseline in contrast sensitivity
timeFrame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.