Posterior Capsule OpacificationNCT03857412
Posterior Capsule Opacification After Lens Capsule Polishing
A study testing Capsular polishing and Non capsular polishing in people with Posterior Capsule Opacification, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- Capsular polishing and Non capsular polishing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 13 Feb 2019to 1 Feb 2021
- Phase
- Interventional
- 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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract.
- Patients in the age group of 21 years and above.
- Patients with uncomplicated cataract.
- Patients without any relevant systemic or ocular morbidity.
- Patients with well dilating pupils.
- Written informed consent prior to any study specific action.
Who cannot join
- Patients with complicated cataract.
- Patients having corneal pathology.
- Patients with any form of ocular inflammation.
- Patients with glaucoma, retinal pathologies.
- Patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation.
- Any intraoperative complications like posterior capsule rupture.
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Andreea Fisus, MD, 01 91021-57564, office@viros.at
Manuel Ruiß, MSc., 01 91021-57564, office@viros.at
About this study
Official title: Evaluation of Intraoperative Capsular Polishing on Lens Epithelial Cells and the Development of Posterior Capsule Opacification
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification
Read the detailed description
Cataract, the clouding if the eye's lens, is the leading cause of blindness worldwide, with phacoemulsification and implantation of an intraocular lens being the only therapeutic option. Cataract surgery is nowadays considered a safe and efficient procedure. However, one of the most frequent complications after surgery is posterior capsule opacification (PCO), that results in diminished postoperative visual acuity. PCO occurs due to remaining lens epithelial cells in the capsular bag, that start to migrate and proliferate.
PCO can be easily treated by performing a neodymium-doped yttrium aluminium garnet (Nd-YAG) laser capsulotomy. However, even if laser capsulotomy is considered a simple procedure, possible complications are rise of intraocular pressure, inflammation, cystoid macular edema, or retinal detachment. Furthermore, several patients are no suitable candidates for laser capsulotomy, for example children and patients with high myopia.
Therefore, it would be necessery to identify different approaches to prevent generation of PCO. One approach could be "cleaning" of the lens epithelial cells in the capsular bag by polishing of the lens capsule during surgery. Hence, the aim of this study is to examine whether capsular polishing is beneficial to decrease the growth and proliferation of LECs.
- Conditions
- Posterior Capsule Opacification
- Being tested
- Capsular polishing, Non capsular polishing
- Keywords
- Polishing, Cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular polishingProcedure or surgery
Capsular polishing taking place during cataract surgery
Non capsular polishingOther
No capsular polishing taking place during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Non capsular polishing | Sham comparator | No capsular polishing taking place during cataract surgery Receives: Other: Non capsular polishing |
| Capsular polishing | Active comparator | Capsular polishing taking place during cataract surgery Receives: Procedure: Capsular polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient
Posterior capsule opacification will be graded using a score from 0 (clear capsule) to 10 (very severe PCO)
Measured: 6 months
Secondary outcomes (1)
Difference in the number of cells in the anterior chamber between the eye with capsular polishing and the eye without capsular polishing in the same patient
Number of cells in the anterior chamber will be rated using a laser flare meter
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start13 Feb 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857412
- Sponsor's protocol ID
- Polishing
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Capsular Polishing on Lens Epithelial Cells and the Development of Posterior Capsule Opacification
- ClinicalTrials.gov ID
- NCT03857412
- Acronym / sponsor ID
- Polishing
- Conditions
- Posterior Capsule Opacification
- Keywords
- Polishing, Cataract surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 28 Feb 2019 (actual)
- 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.
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification
Detailed description
Cataract, the clouding if the eye's lens, is the leading cause of blindness worldwide, with phacoemulsification and implantation of an intraocular lens being the only therapeutic option. Cataract surgery is nowadays considered a safe and efficient procedure. However, one of the most frequent complications after surgery is posterior capsule opacification (PCO), that results in diminished postoperative visual acuity. PCO occurs due to remaining lens epithelial cells in the capsular bag, that start to migrate and proliferate.
PCO can be easily treated by performing a neodymium-doped yttrium aluminium garnet (Nd-YAG) laser capsulotomy. However, even if laser capsulotomy is considered a simple procedure, possible complications are rise of intraocular pressure, inflammation, cystoid macular edema, or retinal detachment. Furthermore, several patients are no suitable candidates for laser capsulotomy, for example children and patients with high myopia.
Therefore, it would be necessery to identify different approaches to prevent generation of PCO. One approach could be "cleaning" of the lens epithelial cells in the capsular bag by polishing of the lens capsule during surgery. Hence, the aim of this study is to examine whether capsular polishing is beneficial to decrease the growth and proliferation of LECs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non capsular polishing | Sham comparator | Other: Non capsular polishingNo capsular polishing taking place during cataract surgery |
| Capsular polishing | Active comparator | Procedure: Capsular polishingCapsular polishing taking place during cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age-related cataract.
- Patients in the age group of 21 years and above.
- Patients with uncomplicated cataract.
- Patients without any relevant systemic or ocular morbidity.
- Patients with well dilating pupils.
Key exclusion criteria (7 listed)
- Patients with complicated cataract.
- Patients having corneal pathology.
- Patients with any form of ocular inflammation.
- Patients with glaucoma, retinal pathologies.
- Patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation.
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 |
|---|---|---|
| Capsular polishingCapsular polishing taking place during cataract surgery | Procedure or surgery | Capsular polishing |
| Non capsular polishingNo capsular polishing taking place during cataract surgery | Other | Non capsular polishing |
Primary outcome
Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient
Time frame: 6 months
Posterior capsule opacification will be graded using a score from 0 (clear capsule) to 10 (very severe PCO)
1 secondary outcome
Difference in the number of cells in the anterior chamber between the eye with capsular polishing and the eye without capsular polishing in the same patient
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsular polishing and Non capsular polishing in people with Posterior Capsule Opacification, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
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 6 inclusion and 7 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 16 Mar 2020. 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 Austria. 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. Some participants in this study may receive a placebo. 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 Andreea Fisus, MD (01 91021-57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between eye with capsular polishing and eye without capsular polishing concerning generation of posterior capsule opacification (PCO) in the same patient (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2020.