Posterior Capsule Opacification After Lens Capsule Polishing

Posterior Capsule Opacification Clinical Trial

Official title:

Evaluation of Intraoperative Capsular Polishing on Lens Epithelial Cells and the Development of Posterior Capsule Opacification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857412
• Other study ID #: Polishing
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Andreea Fisus, MD
• Phone: 01 91021-57564
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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)

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification

Intervention

Procedure:
• Capsular polishing
Capsular polishing taking place during cataract surgery

Other:
• Non capsular polishing
No capsular polishing taking place during cataract surgery

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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