Posterior Capsule Opacification After Lens Capsule Polishing

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA (Other)
Overall Status
Unknown status
CT.gov ID
NCT03857412
Collaborator
(none)
40
1
2
23.6
1.7

Study Details

Study Description

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
  • Procedure: Capsular polishing
  • Other: Non capsular polishing
N/A

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

Study Type:
Interventional
Anticipated 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 :
Feb 13, 2019
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

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

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 [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 [6 months]

    Number of cells in the anterior chamber will be rated using a laser flare meter

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery (VIROS) Vienna Austria 1140

Sponsors and Collaborators

  • Prim. Prof. Dr. Oliver Findl, MBA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Feb 28, 2019
Last Update Posted:
Mar 16, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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, Principle Investigator, Vienna Institute for Research in Ocular Surgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2020