Posterior Capsule Opacification After Lens Capsule Polishing

Prim. Prof. Dr. Oliver Findl, MBA

Status: Unknown

Conditions: Posterior Capsule Opacification

Treatments: Other: Non capsular polishing; Procedure: Capsular polishing

Study type: Interventional

Funder types: Other

Identifiers

NCT03857412

Polishing

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Non capsular polishing

Sham Comparator group

Description:

No capsular polishing taking place during cataract surgery

Treatment:

Other: Non capsular polishing

Capsular polishing

Active Comparator group

Description:

Capsular polishing taking place during cataract surgery

Treatment:

Procedure: Capsular polishing