Anterior Capsule Polishing Effect on Effective Lens Position

A study testing anterior capsule polishing in people with Cataract, run by Shandong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD) patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag… Read more about this study

Who is it for?: Any age
Conditions the study is for: Cataract
What is being tested?: anterior capsule polishing
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: Jan 2013to Jan 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

bilateral age-related cataract
good overall physical constitution
uneventful surgeries of both eyes with in-the-bag IOL implantation

Who cannot join

history of intraocular surgery or laser therapy
history of ocular trauma or ocular disease
high myopia
diabetes
severe retinal pathology
patients who could not return on time

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Ophtalmology,Qianfoshan Hospital,Shandong University
Jinan, Shandong, 250013

Other trials in China

About this study

Official title: Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery

The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)
patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.

Conditions: Cataract
Being tested: anterior capsule polishing
Keywords: age related cataract, phacoemulsification, anterior capsule polishing, optical coherence tomography, anterior chamber depth
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

anterior capsule polishingProcedure or surgery
polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher

Study groups in NCT01598428
Study group	Role	What they receive
cataract	Other	Not described Receives: Procedure: anterior capsule polishing

What is being measured

The primary outcome is the main question the study is designed to answer.

Effective Lens Position
Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.
Measured: 1 day，1 week, 1 month，3 months and 6 months postoperatively

Secondary outcomes (2)

Uncorrected Visual Acuity(UCVA)
The UCVA was recorded in logMAR units at each vist
Measured: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
Refractive Error
auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.
Measured: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jan 2014

First posted15 May 2012 (estimated)
Study startJan 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01598428
Sponsor's protocol ID: YGao
Status last verified: Jan 2015
First submitted: 8 May 2012
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery
ClinicalTrials.gov ID: NCT01598428
Acronym / sponsor ID: YGao
Conditions: Cataract
Keywords: age related cataract, phacoemulsification, anterior capsule polishing, optical coherence tomography, anterior chamber depth
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Shandong UniversityUniversity, hospital or other
Study start: Jan 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 15 May 2012 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)
patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
cataract	Other	Procedure: anterior capsule polishing

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

bilateral age-related cataract
good overall physical constitution
uneventful surgeries of both eyes with in-the-bag IOL implantation

Key exclusion criteria (6 listed)

history of intraocular surgery or laser therapy
history of ocular trauma or ocular disease
high myopia
diabetes
severe retinal pathology

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
anterior capsule polishingpolish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher	Procedure or surgery	cataract

Primary outcome

Effective Lens Position
Time frame: 1 day，1 week, 1 month，3 months and 6 months postoperatively
Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.

2 secondary outcomes

Uncorrected Visual Acuity(UCVA)
Time frame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
Refractive Error
Time frame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cataract	20	20

Primary outcome: Effective Lens Position

Time frame: 1 day，1 week, 1 month，3 months and 6 months postoperatively. Mean (Standard Deviation). Unit: mm

Measure	Control n = 20	Anterior Capsule Polishing n = 20
ELP 1 day postoperative	3.97 (0.27)	4.02 (0.32)
ELP 1 week postoperative	3.93 (0.25)	3.99 (0.29)
ELP 1 month postoperative	3.97 (0.23)	3.99 (0.26)
ELP 3 months postoperative	3.98 (0.24)	3.97 (0.27)
ELP 6 months postoperative	3.92 (0.25)	3.97 (0.28)
the root mean square of changes in the ELP(ELPrms)	0.06 (0.02)	0.05 (0.02)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cataract	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing anterior capsule polishing in people with Cataract, run by Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective Lens Position (time frame: 1 day，1 week, 1 month，3 months and 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01598428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.