FLACS vs Phaco in Shallow Anterior Chamber

NCT03587909 | Completed DMC

• 1 other identifier: FLACS1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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?

Conditions

Cataract Surgery; Shallow Anterior Chamber; Phacoemulsification

Keywords

FLACS; Phaco; Shallow Anterior Chamber

Outcome Measures

Primary Outcomes (1)

• Central Corneal Thickness

  Central Corneal Thickness

  Postoperative Day 1

Secondary Outcomes (2)

• Anterior Chamber Inflammation

  Postoperative Day 1

• Endothelial Cell Morphology

  Postoperative 6 months

Study Arms (2)

Phacoemulsification Cataract Surgery

ACTIVE COMPARATOR

Procedure / Surgery : Phacoemulsification Surgery

Procedure: Phacoemulsification Cataract SUrgery

Femtosecond Cataract Surgery

ACTIVE COMPARATOR

Procedure / SUrgery - Femtosecond Laser Cataract surgery

Procedure: Femtosecond Cataract Surgery

Interventions

Phacoemulsification Cataract SUrgery PROCEDURE

Phacoemulsification in eyes with shallow anterior chamber (\<2.5mm depth)

Phacoemulsification Cataract Surgery

Femtosecond Cataract Surgery PROCEDURE

Femtosecond Cataract Surgery in eyes with shallow anterior chamber \< 2.5mm

Femtosecond Cataract Surgery

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uncomplicated, age related cataracts
• Shallow anterior chamber (measured as \</=2.5mm )

You may not qualify if:

• Coexisting ocular morbidity,
• inability to come for followup

Sponsors & Collaborators

• Iladevi Cataract and IOL Research Center: lead

Study Sites (1)

Iladevi Cataract & IOL Research Center

Ahmedabad, Gujarat, 380052, India

Location

Study Officials

• Abhay Vasavada, MS,FRCS

  Iladevi Cataract & IOL Research Centre, Ahmedabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 16, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 15, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)