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Posterior Capsule Opacification After Lens Capsule Polishing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03857412
Recruitment Status : Unknown
Verified March 2020 by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery.
Recruitment status was:  Recruiting
First Posted : February 28, 2019
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Study Description
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Brief Summary:
Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification

Condition or disease Intervention/treatment Phase
Posterior Capsule Opacification Procedure: Capsular polishing Other: Non capsular polishing Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Intraoperative Capsular Polishing on Lens Epithelial Cells and the Development of Posterior Capsule Opacification
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Non capsular polishing
No capsular polishing taking place during cataract surgery
 Other: Non capsular polishing
No capsular polishing taking place during cataract surgery
Active Comparator: Capsular polishing
Capsular polishing taking place during cataract surgery
 Procedure: Capsular polishing
Capsular polishing taking place during cataract surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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 [ Time Frame: 6 months ]
    Number of cells in the anterior chamber will be rated using a laser flare meter


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857412


Contacts
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Contact: Andreea Fisus, MD 01 91021-57564 office@viros.at
Contact: Manuel Ruiß, MSc. 01 91021-57564 office@viros.at

Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS) Recruiting
Vienna, Austria, 1140
Contact: Andreea Fisus, MD    01 91021-57564    office@viros.at   
Contact: Manuel Ruiß, MSc.    01 91021-57564    office@viros.at   
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA
More Information
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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principle Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03857412    
Other Study ID Numbers: Polishing
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
Polishing
Cataract surgery
Additional relevant MeSH terms:
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Capsule Opacification
Cataract
Lens Diseases
Eye Diseases