Posterior Capsule Opacification After Lens Capsule Polishing

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

Study Overview

• Status: Unknown
• Conditions: Posterior Capsule Opacification
• Intervention / Treatment: Other: Non capsular polishing; Procedure: Capsular polishing

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreea Fisus, MD; Phone Number: 01 91021-57564; Email: office@viros.at
• Study Contact Backup: Name: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS)
    • Contact: Andreea Fisus, MD; Phone Number: 01 91021-57564; Email: office@viros.at
    • Contact: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 103 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cataract surgery; Polishing
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: Polishing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No