FLACS vs Phaco in Shallow Anterior Chamber

• Sponsor: Iladevi Cataract and IOL Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03587909
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 7.3

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Cataract Surgery; Shallow Anterior Chamber; Phacoemulsification	Procedure: Phacoemulsification Cataract SUrgery; Procedure: Femtosecond Cataract Surgery	N/A

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:

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 (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

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jan 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Central Corneal Thickness [Postoperative Day 1]

   Central Corneal Thickness

Secondary Outcome Measures

1. Anterior Chamber Inflammation [Postoperative Day 1]

   Anterior chamber cells and flare (Hogan's criteria)

2. Endothelial Cell Morphology [Postoperative 6 months]

   Endothelial Cell Density

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• uncomplicated, age related cataracts

• Shallow anterior chamber (measured as </=2.5mm )

Exclusion Criteria:

• Coexisting ocular morbidity,

• inability to come for followup

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iladevi Cataract & IOL Research Center	Ahmedabad	Gujarat	India	380052

Sponsors and Collaborators

• Iladevi Cataract and IOL Research Center

Investigators

• Principal Investigator: Abhay Vasavada, MS,FRCS, Iladevi Cataract & IOL Research Centre, Ahmedabad

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abhay R. Vasavada, Principal Investigator, Iladevi Cataract and IOL Research Center
• ClinicalTrials.gov Identifier: NCT03587909
• Other Study ID Numbers: FLACS1
• First Posted: Jul 16, 2018
• Last Update Posted: Jul 16, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abhay R. Vasavada, Principal Investigator, Iladevi Cataract and IOL Research Center: FLACS; Phaco; Shallow Anterior Chamber
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jul 16, 2018