Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03587909
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2018-06-11
Brief Title:
FLACS vs Phaco in Shallow Anterior Chamber
Sponsor:
Iladevi Cataract and IOL Research Center
Organization:
Iladevi Cataract and IOL Research Center
Study Overview
Official Title:
Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery FLACS and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phacoemulsification in eyes with a shallow anterior chamber ACD 22mm presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemets 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
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 25mm
Exclusion Criteria
-Ocular co-morbidity - corneal disorders glaucoma uveitis previous ocular surgery
Surgical Technique
Standardized Single Surgeon
22 mm clear corneal temporal incision
FLACS Group Capsulorhexis Lens Fragmentation with femto laser
The investigators will be evaluating the following parameters
1 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
2 Secondary outcome measures
Corneal clarity -on day 1 week 1 and 1 month postoperatively
Anterior chamber cells and flare Hogans 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
3 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
Age-related cataract
Shallow Anterior Chamber 25mm
Exclusion Criteria
-Ocular co-morbidity - corneal disorders glaucoma uveitis previous ocular surgery
Surgical Technique
Standardized Single Surgeon
22 mm clear corneal temporal incision
FLACS Group Capsulorhexis Lens Fragmentation with femto laser
The investigators will be evaluating the following parameters
1 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
2 Secondary outcome measures
Corneal clarity -on day 1 week 1 and 1 month postoperatively
Anterior chamber cells and flare Hogans 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
3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None