Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence

Study Overview
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Brief Summary
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The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. Cataract surgery will be performed in subjects who have signed an informed consent form. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.

Official Title
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Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation

Conditions
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Age Related Cataracts

Intervention / Treatment
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* Device: Femtosecondlaser-assisted
* Procedure: Anterior Capsulotomy
* Procedure: Lens Fragmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible) Preoperative pupil dilation in mydriasis ≥ 6.5 mm Exclusion Criteria: Preceding ocular surgery or trauma Recurrent intraocular inflammation of unknown etiology Uncontrolled glaucoma Uncontrolled systemic or ocular disease Blind fellow eye Microphthalmus Corneal abnormality History of uveitis/iritis Iris neovascularization Pseudoexfoliation Proliferative diabetic retinopathy Pregnancy Lactation Females of childbearing age: not included

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Bilateral femtosecond-laser assisted cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either anterior capsulotomy before lens fragmentation or vice versa in the contralateral eye. After laser procedure samples of aqueous humor will be collected and when complete all samples will be analysed by ELISA for Prostaglandin.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior Capsulotomy before Lens Fragmentation<br>Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation | Device: Femtosecondlaser-assisted<br>* Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.<br>* Other names: Laser assisted Cataract Surgery;Procedure: Anterior Capsulotomy<br>* Cataract Surgery<br>|
| Active Comparator: Lens Fragmentation before Anterior Capsulotomy<br>Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy | Device: Femtosecondlaser-assisted<br>* Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.<br>* Other names: Laser assisted Cataract Surgery;Procedure: Lens Fragmentation<br>* Cataract Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total-Prostaglandin and PGE2 level in aqueous humor | pg/mL | 5 minutes after laser procedure (LCS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pupilsize | in mm | baseline, immediately after laser, 5 min after laser | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Cataract Surgery