Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Cataract Clinical Trial

Official title:

Effectiveness of Two Different Surgical Procedures to Prevent Posterior Capsule Opacification in Age-related Cataract Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02445274
• Other study ID #: 2015MEKY046
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2015
• Last updated: April 29, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: Haotian Lin, M.D., PhD
• Phone: 8613802793086
• Email: haot.lin[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Posterior Capsule Opacification

Intervention

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.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in best corrected visual acuity	Best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist.	post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1	No
Other	Change from Baseline in contrast sensitivity	Contrast sensitivity under mesopic and photopic conditions was measured using C-quant	post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1	No
Primary	Change from Baseline in posterior capsule opacification grading score	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)	post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3,	No
Secondary	Change from Baseline in central posterior capsule thickness	Central posterior capsule thickness was recorded and calculated by Pentacam HR system	post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1	No
Secondary	Change from Baseline in central posterior capsule density	Central posterior capsule density was recorded and calculated by Pentacam HR system.	post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1	No

External Links

•   Homepage for Zhongshan Ophthalmic Center