Posterior Capsule Opacification After Lens Capsule Polishing

Not Applicable

• Conditions: Posterior Capsule Opacification
• Interventions: Other: Non capsular polishing; Procedure: Capsular polishing

• Registration Number: NCT03857412
• Lead Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Brief Summary

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 Timeline

• Study Start: 2019-02-13
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16
• Primary Completion: 2020-05-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non capsular polishing	Non capsular polishing	No capsular polishing taking place during cataract surgery
Capsular polishing	Capsular polishing	Capsular polishing taking place during cataract surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS); 🇦🇹 Vienna, Austria