FLACS vs Phaco in Shallow Anterior Chamber

NCT ID: NCT03587909

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-01-15

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:

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

Conditions

Cataract Surgery; Shallow Anterior Chamber; Phacoemulsification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phacoemulsification Cataract Surgery

Procedure / Surgery : Phacoemulsification Surgery

Group Type: ACTIVE_COMPARATOR

Phacoemulsification Cataract SUrgery

Intervention Type: PROCEDURE

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

Femtosecond Cataract Surgery

Procedure / SUrgery - Femtosecond Laser Cataract surgery

Group Type: ACTIVE_COMPARATOR

Femtosecond Cataract Surgery

Intervention Type: PROCEDURE

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

Interventions

Phacoemulsification Cataract SUrgery

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

Intervention Type: PROCEDURE

Femtosecond Cataract Surgery

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role: lead

Responsible Party

Abhay R. Vasavada

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abhay Vasavada, MS,FRCS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract & IOL Research Centre, Ahmedabad

Locations

Iladevi Cataract & IOL Research Center

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

FLACS1

Identifier Type: -

Identifier Source: org_study_id