FLACS vs Phaco in Shallow Anterior Chamber

Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587909
• Other study ID #: FLACS1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: July 2018
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 15, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

Inclusion Criteria:

• uncomplicated, age related cataracts

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

Exclusion Criteria:

• Coexisting ocular morbidity,

• inability to come for followup

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Phacoemulsification
• Shallow Anterior Chamber

Intervention

Procedure:
• Phacoemulsification Cataract SUrgery
Phacoemulsification in eyes with shallow anterior chamber (<2.5mm depth)
• Femtosecond Cataract Surgery
Femtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm

Locations

Country	Name	City	State
India	Iladevi Cataract & IOL Research Center	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Corneal Thickness	Central Corneal Thickness	Postoperative Day 1
Secondary	Anterior Chamber Inflammation	Anterior chamber cells and flare (Hogan's criteria)	Postoperative Day 1
Secondary	Endothelial Cell Morphology	Endothelial Cell Density	Postoperative 6 months