Posterior Capsule Opacification After Lens Capsule Polishing

NCT ID: NCT03857412

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2021-02-01

Brief Summary

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Investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification

Detailed Description

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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

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Posterior Capsule Opacification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Non capsular polishing

No capsular polishing taking place during cataract surgery

Group Type SHAM_COMPARATOR

Non capsular polishing

Intervention Type OTHER

No capsular polishing taking place during cataract surgery

Capsular polishing

Capsular polishing taking place during cataract surgery

Group Type ACTIVE_COMPARATOR

Capsular polishing

Intervention Type PROCEDURE

Capsular polishing taking place during cataract surgery

Interventions

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Capsular polishing

Capsular polishing taking place during cataract surgery

Intervention Type PROCEDURE

Non capsular polishing

No capsular polishing taking place during cataract surgery

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Andreea Fisus, MD

Role: CONTACT

01 91021-57564

Manuel Ruiß, MSc.

Role: CONTACT

01 91021-57564

Facility Contacts

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Andreea Fisus, MD

Role: primary

01 91021-57564

Manuel Ruiß, MSc.

Role: backup

01 91021-57564

Other Identifiers

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Polishing

Identifier Type: -

Identifier Source: org_study_id

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