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Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Primary Purpose

Cataract, Posterior Capsule Opacification

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anterior lens capsule was reserved
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Capsule-reserved surgical procedure

Conventional surgical procedure

Arm Description

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.

In this group, the anterior lens capsule was not reserved or attached onto the posterior lens capsule.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change from Baseline in central posterior capsule thickness
Central posterior capsule thickness was recorded and calculated by Pentacam HR system
Change from Baseline in central posterior capsule density
Central posterior capsule density was recorded and calculated by Pentacam HR system.

Full Information

First Posted
May 4, 2015
Last Updated
April 29, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02445274
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Posterior Capsule Opacification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capsule-reserved surgical procedure
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional surgical procedure
Arm Type
No Intervention
Arm Description
In this group, the anterior lens capsule was not reserved or attached onto the posterior lens capsule.
Intervention Type
Procedure
Intervention Name(s)
Anterior lens capsule was reserved
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in posterior capsule opacification grading score
Description
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)
Time Frame
post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3,
Secondary Outcome Measure Information:
Title
Change from Baseline in central posterior capsule thickness
Description
Central posterior capsule thickness was recorded and calculated by Pentacam HR system
Time Frame
post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1
Title
Change from Baseline in central posterior capsule density
Description
Central posterior capsule density was recorded and calculated by Pentacam HR system.
Time Frame
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 Pre-specified Outcome Measures:
Title
Change from Baseline in best corrected visual acuity
Description
Best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist.
Time Frame
post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1
Title
Change from Baseline in contrast sensitivity
Description
Contrast sensitivity under mesopic and photopic conditions was measured using C-quant
Time Frame
post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 50 years or above Both eyes were diagnosed with age-related cataract Both eyes were planed to undergo the "Phacoemulsification and IOL implantation" surgery with 1 month Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists. Exclusion Criteria: Other ocular diseases ACD<3CT Combined cataract surgery (trabeculoplasty, keratoplasty) Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities Previous intraocular surgery or trauma (laser not included) Uveitis Recent ocular infection Proliferative diabetic retinopathy Diabetes mellitus Congenital ocular abnormalities (aniridia, congenital cataract) Atrophy of iris Participants with previous clinical trials 30 days before surgery Using prostanoid eye drops Uncontrolled systematic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haotian Lin, M.D., PhD
Phone
8613802793086
Email
haot.lin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohang Wu, M.D.
Phone
+86-20-87330341
Email
1034281949@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D., PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D.
Phone
8613802793086
Email
haot.lin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jing Li, M.D.
Phone
+86-20-87330341
Email
Reviewborad_SYsU@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25401512
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.
Results Reference
background
PubMed Identifier
23499067
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.
Results Reference
background
PubMed Identifier
22553760
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.
Results Reference
background
PubMed Identifier
22310081
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.
Results Reference
result
Links:
URL
http://www.gzzoc.com
Description
Homepage for Zhongshan Ophthalmic Center

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Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

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