Posterior Capsule Opacification After Lens Capsule Polishing

Study Overview
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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.

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

Conditions
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Posterior Capsule Opacification

Intervention / Treatment
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* Procedure: Capsular polishing
* Other: Non capsular polishing


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Non capsular polishing<br>No capsular polishing taking place during cataract surgery | Other: Non capsular polishing<br>* No capsular polishing taking place during cataract surgery<br>|
| Active Comparator: Capsular polishing<br>Capsular polishing taking place during cataract surgery | Procedure: Capsular polishing<br>* Capsular polishing taking place during cataract surgery<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polishing, Cataract surgery