FLACS vs Phaco in Shallow Anterior Chamber
Primary Purpose
Cataract Surgery, Shallow Anterior Chamber, Phacoemulsification
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Phacoemulsification Cataract SUrgery
Femtosecond Cataract Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Surgery focused on measuring FLACS, Phaco, Shallow Anterior Chamber
Eligibility Criteria
Inclusion Criteria:
- uncomplicated, age related cataracts
- Shallow anterior chamber (measured as </=2.5mm )
Exclusion Criteria:
- Coexisting ocular morbidity,
- inability to come for followup
Sites / Locations
- Iladevi Cataract & IOL Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Phacoemulsification Cataract Surgery
Femtosecond Cataract Surgery
Arm Description
Procedure / Surgery : Phacoemulsification Surgery
Procedure / SUrgery - Femtosecond Laser Cataract surgery
Outcomes
Primary Outcome Measures
Central Corneal Thickness
Central Corneal Thickness
Secondary Outcome Measures
Anterior Chamber Inflammation
Anterior chamber cells and flare (Hogan's criteria)
Endothelial Cell Morphology
Endothelial Cell Density
Full Information
NCT ID
NCT03587909
First Posted
June 11, 2018
Last Updated
July 3, 2018
Sponsor
Iladevi Cataract and IOL Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03587909
Brief Title
FLACS vs Phaco in Shallow Anterior Chamber
Official Title
Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iladevi Cataract and IOL Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery, Shallow Anterior Chamber, Phacoemulsification
Keywords
FLACS, Phaco, Shallow Anterior Chamber
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phacoemulsification Cataract Surgery
Arm Type
Active Comparator
Arm Description
Procedure / Surgery : Phacoemulsification Surgery
Arm Title
Femtosecond Cataract Surgery
Arm Type
Active Comparator
Arm Description
Procedure / SUrgery - Femtosecond Laser Cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification Cataract SUrgery
Intervention Description
Phacoemulsification in eyes with shallow anterior chamber (<2.5mm depth)
Intervention Type
Procedure
Intervention Name(s)
Femtosecond Cataract Surgery
Intervention Description
Femtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm
Primary Outcome Measure Information:
Title
Central Corneal Thickness
Description
Central Corneal Thickness
Time Frame
Postoperative Day 1
Secondary Outcome Measure Information:
Title
Anterior Chamber Inflammation
Description
Anterior chamber cells and flare (Hogan's criteria)
Time Frame
Postoperative Day 1
Title
Endothelial Cell Morphology
Description
Endothelial Cell Density
Time Frame
Postoperative 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
uncomplicated, age related cataracts
Shallow anterior chamber (measured as </=2.5mm )
Exclusion Criteria:
Coexisting ocular morbidity,
inability to come for followup
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhay Vasavada, MS,FRCS
Organizational Affiliation
Iladevi Cataract & IOL Research Centre, Ahmedabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Center
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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FLACS vs Phaco in Shallow Anterior Chamber
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