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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

240

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2015

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

May 1, 2015

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed

11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed

Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

May 4, 2015

Last Update Submit

April 29, 2016

Conditions

Cataract Posterior Capsule Opacification

Outcome Measures

Primary Outcomes (1)

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,

Secondary Outcomes (2)

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
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

Other Outcomes (2)

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
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

Study Arms (2)

Capsule-reserved surgical procedure

EXPERIMENTAL

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

Conventional surgical procedure

NO INTERVENTION

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

Interventions

Anterior lens capsule was reservedPROCEDURE

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.

Capsule-reserved surgical procedure

Eligibility Criteria

Age50 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sun Yat-sen Universitylead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

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.
PMID: 25401512BACKGROUND
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.
PMID: 23499067BACKGROUND
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.
PMID: 22553760BACKGROUND
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.
PMID: 22310081RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

Yizhi Liu, M.D., PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Haotian Lin, M.D., PhD

CONTACT

8613802793086 haot.lin@hotmail.com

Xiaohang Wu, M.D.

CONTACT

+86-20-87330341 1034281949@qq.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 15, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-04

Locations

CN(1)

Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Study Arms (2)

Capsule-reserved surgical procedure

Conventional surgical procedure

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Study Arms (2)

Capsule-reserved surgical procedure

Conventional surgical procedure

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations