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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03587909
Other study ID # FLACS1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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