Comparison of Femto-laser and Manually Created Clear Corneal Incisions During Cataract Surgery

Study Overview
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Brief Summary
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The aim of this study is to test the hypothesis, that in terms of Surgically Induced corneal Astigmatism (SIA), Higher-order Aberrations (HOA), and wound geometry the femtosecond clear corneal incisions (CCIs) created during cataract surgery are not inferior when compared to manual CCIs. The potential risks associated with application of the femtosecond laser in this study are no greater or in most cases less than those associated with the standard manual cataract surgical procedure, and the potential benefits (such as precision and reproducibility) are greater than with the standard manual cataract surgery. Therefore, the risk-to-benefit ratio is very low, such that the potential benefits for a subject participating in this study exceed the potential risks

Official Title
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A Single Center, Randomized Control Study to Compare Efficacy and Safety of Femto-laser Created Clear Corneal Incisions With Manually Created Clear Corneal Incisions During Cataract Surgery

Conditions
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Cataract

Intervention / Treatment
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* Device: Femtosecond Laser for Cataract Surgery
* Other: Conventional Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataract surgery planned Accurate baseline biometric measurements and assessed medical status Subject able to cooperate with the docking system of the laser Full pupil dilatation Exclusion Criteria: Glaucoma Pseudoexfoliation Small pupils Previous corneal surgery Other ophthalmological diseases Corneal scars Pterygium

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femtosecond Laser for Cataract Surgery<br>Capsulotomy, lens fragmentation and Clear Corneal Incisions with FEMTO LDV Z8, followed by ultrasound phacoemulsification and IOL implantation. | Device: Femtosecond Laser for Cataract Surgery<br>* Cataract Surgery on study eye according to conventional procedure, with the exception of three steps (Capsulotomy, Lens Fragmentation and Clear Corneal Incisions) which are performed with a Femtosecond Laser in the laser treatment group. Equipment uesd for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment<br>|
| Active Comparator: Conventional Cataract Surgery<br>Clear Corneal Incisions, conventional capsulorhexis and ultrasound phacoemulsification and IOL implantation. Control treatment where the clear corneal incisions and capsulorhexis are performed manually and the lens fragmentation is performed with the phacoemulsification device. | Other: Conventional Cataract Surgery<br>* Cataract surgery will be performed conventionally, this means the clear corneal incisions will be performed manually by a blade, the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by visual acuity (LogMAR) |  | Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (pre-operative) Higher-order aberrations (HOAs) measured by the Shack-Hartmann aberrometry method |  | Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery | 
| Central corneal thickness (CCT) |  | Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery | 
| Endothelial cell density (ECD) |  | Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery | 
| Effective Phacoemulsification Time (EPT) |  | Baseline = Treatment day | 
| Ultrasound total time (US) |  | Baseline = Treatment day | 
| Achieved CCI architecture | Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images | Baseline = Treatment day | 
| Intra- and post-operative CCI related complications rate |  | Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery | 
| FEMTO LDV Z8 OCT auto - detection accuracy | Analyzed on intra-operative Z8 OCT images | Baseline = Treatment day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced corneal Astigmatism, Clear corneal incisions, Femto-laser