Capsule OpacificationNCT01605812
Evaluate Capsular Apposition to Intraocular Lens
An observational study of Capsule Opacification and Tissue Adhesions, run by Wenzhou Medical University at 1 site in China.
Trial summary
In this study, the investigators examined the capsule-IOL interaction including anterior and posterior capsule adhesion, contact between posterior capsule and the posterior edge of intraocular lense (IOL), configuration of capsular bend and the incidence of posterior capsular opacity (PCO) between high myopia eyes and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Capsule Opacification, Tissue Adhesions, Aphakia - Lens Capsule Present
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: This prospective study consisted consecutive patients with high axial myopia (myopia group) and age-matched patients with normal axial length (control group). All eyes underwent uncomplicated phacoemulsification with a single-piece IOL (AcrySof, Alcon) implantation for cataract treatment.
Who may be able to join
- Eyes with an AL of 26.00mm or more were recruited to the high myopia group.
- Eyes with an AL of 22.00 to 25.00 mm were recruited to the emmetropia group.
Who cannot join
- Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation, pupils could not be dilated over 7mm after mydriasis,
- patients who could not be available for follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenzhou Medical University
Wenzhou, Zhejiang, 325027
XIXIA DING, PHD, 86-057788068859
About this study
Official title: Phase 1 Evaluate Capsular Apposition to Intraocular Lens in Subjects With High Myopia by Ultra-long Scan Depth Optical Coherence Tomography; Phase 2 Evaluate Capsular Apposition to Different Types of Intraocular Lens in Subjects
In this study, the investigators examined the capsule-IOL interaction including anterior and posterior capsule adhesion, contact between posterior capsule and the posterior edge of intraocular lense (IOL), configuration of capsular bend and the incidence of posterior capsular opacity (PCO) between high myopia eyes and emmetropia eyes.
Read the detailed description
150 eyes of 150 cataract patients scheduled for phacoemulsification surgery were recruited, of which 20 eyes were high myopia (AL > 26mm) and 40 eyes were emmetropia (22 < AL < 25mm) as control group.High myopia eyes and 20 emmetropia eyes were implanted with the single-piece hydrophobic acrylic IOL (Acrysof IQ SN60WF, Alcon laboratories, Inc. IQ group). Another 20 emmetropia eyes were implanted with the other single-piece hydrophilic acrylic IOL (Akreos Adapt, Bausch \&Lomb, AO group).80 eyes implanted with the single-piece hydrophobic acrylic IOL were examined by SSOCT to build the 3-D model of anterior segment.
Methods: 60 eyes were examined by custom-built UL-OCT at 4 hours, 1 day, 7 day, 14 day, 28 day, 3 month, 6 month,12 month after surgery.30 eyes implanted with the single-piece hydrophobic acrylic IOL were recruited for evaluation of the SSOCT reliability.50 eyes were examined by SSOCT at 1 day, 7 day,1 month, 3 months,6 months,12 months after surgery.
Measures: Contact of the anterior and posterior lens capsule with the IOL optic surface was evaluated. Types of capsular bend were described at the last follow-up. The incidence of posterior capsular opacity (PCO) was evaluated.
- Conditions
- Capsule Opacification, Tissue Adhesions, Aphakia - Lens Capsule Present, Opacification of Intraocular Lens
- Keywords
- IOL;, capsule；, PCO;, OCT
- Medical subject headings
- Capsule Opacification, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high myopia | high myopia (axial length>26mm) | |
| emmetropia | emmetropia (22<axial length<25mm) as control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Capsular Apposition to Intraocular Lens in high myopia eyes and emmetropia eyes with different types of IOL
Measured: 4hour, 1day, 7day, 14day, 28day, 3month, 6month, 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Capsule OpacificationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
- Investigators
- yune zhao, MS, Study chair, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605812
- Sponsor's protocol ID
- WZYXY-ZYY-OCT
- Status last verified
- Jan 2015
- First submitted
- 11 May 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tao A, Lu P, Li J, Shao Y, Wang J, Shen M, Zhao Y, Lu F. High resolution OCT quantitative analysis of the space between the IOL and the posterior capsule during the early cataract postoperative period. Invest Ophthalmol Vis Sci. 2013 Oct 25;54(10):6991-7. doi: 10.1167/iovs.13-12849.
PubMed 24065808
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluate Capsular Apposition to Intraocular Lens in Subjects With High Myopia by Ultra-long Scan Depth Optical Coherence Tomography; Phase 2 Evaluate Capsular Apposition to Different Types of Intraocular Lens in Subjects
- ClinicalTrials.gov ID
- NCT01605812
- Acronym / sponsor ID
- WZYXY-ZYY-OCT
- Conditions
- Capsule Opacification, Tissue Adhesions, Aphakia - Lens Capsule Present, Opacification of Intraocular Lens
- Keywords
- IOL;, capsule；, PCO;, OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators examined the capsule-IOL interaction including anterior and posterior capsule adhesion, contact between posterior capsule and the posterior edge of intraocular lense (IOL), configuration of capsular bend and the incidence of posterior capsular opacity (PCO) between high myopia eyes and emmetropia eyes.
Detailed description
150 eyes of 150 cataract patients scheduled for phacoemulsification surgery were recruited, of which 20 eyes were high myopia (AL > 26mm) and 40 eyes were emmetropia (22 < AL < 25mm) as control group.High myopia eyes and 20 emmetropia eyes were implanted with the single-piece hydrophobic acrylic IOL (Acrysof IQ SN60WF, Alcon laboratories, Inc. IQ group). Another 20 emmetropia eyes were implanted with the other single-piece hydrophilic acrylic IOL (Akreos Adapt, Bausch \&Lomb, AO group).80 eyes implanted with the single-piece hydrophobic acrylic IOL were examined by SSOCT to build the 3-D model of anterior segment.
Methods: 60 eyes were examined by custom-built UL-OCT at 4 hours, 1 day, 7 day, 14 day, 28 day, 3 month, 6 month,12 month after surgery.30 eyes implanted with the single-piece hydrophobic acrylic IOL were recruited for evaluation of the SSOCT reliability.50 eyes were examined by SSOCT at 1 day, 7 day,1 month, 3 months,6 months,12 months after surgery.
Measures: Contact of the anterior and posterior lens capsule with the IOL optic surface was evaluated. Types of capsular bend were described at the last follow-up. The incidence of posterior capsular opacity (PCO) was evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high myopia | – | –high myopia (axial length>26mm) |
| emmetropia | – | –emmetropia (22<axial length<25mm) as control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective study consisted consecutive patients with high axial myopia (myopia group) and age-matched patients with normal axial length (control group). All eyes underwent uncomplicated phacoemulsification with a single-piece IOL (AcrySof, Alcon) implantation for cataract treatment.
Key inclusion criteria (2 listed)
- Eyes with an AL of 26.00mm or more were recruited to the high myopia group.
- Eyes with an AL of 22.00 to 25.00 mm were recruited to the emmetropia group.
Key exclusion criteria (2 listed)
- Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation, pupils could not be dilated over 7mm after mydriasis,
- patients who could not be available for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate Capsular Apposition to Intraocular Lens in high myopia eyes and emmetropia eyes with different types of IOL
Time frame: 4hour, 1day, 7day, 14day, 28day, 3month, 6month, 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Derived from this study: PubMed 24065808Tao A, Lu P, Li J, Shao Y, Wang J, Shen M, Zhao Y, Lu F. High resolution OCT quantitative analysis of the space between the IOL and the posterior capsule during the early cataract postoperative period. Invest Ophthalmol Vis Sci. 2013 Oct 25;54(10):6991-7. doi: 10.1167/iovs.13-12849.
Related trials for Capsule Opacification
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Active, not recruitingPhase 4
Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery
Dry Eye Disease (DED)
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
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.
yune zhao, MS study chair
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capsule Opacification and Tissue Adhesions, run by Wenzhou Medical 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yinying zhao, PhD (86-057788068859, ginger146@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Capsular Apposition to Intraocular Lens in high myopia eyes and emmetropia eyes with different types of IOL (time frame: 4hour, 1day, 7day, 14day, 28day, 3month, 6month, 12month). 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 NCT01605812, which also lists 1 linked publication.
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 9 Jan 2015.