FLACS vs Phaco in Shallow Anterior Chamber

Study Overview
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Brief Summary
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Phacoemulsification in eyes with a shallow anterior chamber (ACD < 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. A shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery. Femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. The effective phacoemulsification time and intra-operative manipulation is greatly reduced in FLACS. However phacoemulsification still remains the most widely performed cataract surgery around the world. Post-operative outcomes after phacoemulsification in patients having shallow anterior chamber have been extensively reported in literature over the years. There is no head to head comparison in terms of intraoperative performance and post-operative outcomes between FLACS and phacoemulsification in eyes with shallow anterior chamber. The aim is to compare the intra-operative performance and post-operative outcomes in eyes undergoing femtosecond laser assisted cataract surgery versus eyes undergoing phacoemulsification in eyes having shallow anterior chamber. The study will bring an understanding on the question: Do patients undergoing Femtosecond laser assisted cataract surgery behave differently from those undergoing phacoemulsification?

Detailed Description
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Inclusion Criteria: Age-related cataract Shallow Anterior Chamber (<2.5mm) Exclusion Criteria: -Ocular co-morbidity - corneal disorders, glaucoma, uveitis, previous ocular surgery Surgical Technique : Standardized, Single Surgeon 2.2 mm clear corneal temporal incision FLACS Group : Capsulorhexis, Lens Fragmentation with femto laser The investigators will be evaluating the following parameters: Primary outcome measure Corneal thickness on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant). Secondary outcome measures Corneal clarity -on day 1, week 1 and 1 month postoperatively Anterior chamber cells and flare (Hogan's criteria) Percentage change in endothelial cell density from preoperatively to 3 months postoperatively Unaided visual acuity (distance) on day 1 and 1 month. Best corrected distance visual acuity 1 month postoperatively Other Observations : 1) Cumulative Dissipated Energy (CDE) 2) Surgical time 3) Fluid used 4) Descemets membrane detachment during surgery 5) Incidence of iris trauma 6) Any other intra-operative complications

Official Title
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Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber

Conditions
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Cataract Surgery, Shallow Anterior Chamber, Phacoemulsification

Intervention / Treatment
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* Procedure: Phacoemulsification Cataract SUrgery
* Procedure: Femtosecond Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: uncomplicated, age related cataracts Shallow anterior chamber (measured as </=2.5mm ) Exclusion Criteria: Coexisting ocular morbidity, inability to come for followup

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phacoemulsification Cataract Surgery<br>Procedure / Surgery : Phacoemulsification Surgery | Procedure: Phacoemulsification Cataract SUrgery<br>* Phacoemulsification in eyes with shallow anterior chamber (<2.5mm depth)<br>|
| Active Comparator: Femtosecond Cataract Surgery<br>Procedure / SUrgery - Femtosecond Laser Cataract surgery | Procedure: Femtosecond Cataract Surgery<br>* Femtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Thickness | Central Corneal Thickness | Postoperative Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Inflammation | Anterior chamber cells and flare (Hogan's criteria) | Postoperative Day 1 | 
| Endothelial Cell Morphology | Endothelial Cell Density | Postoperative 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FLACS, Phaco, Shallow Anterior Chamber