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
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 |
Verified date | July 2018 |
Source | Iladevi Cataract and IOL Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
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 |
Country | Name | City | State |
---|---|---|---|
India | Iladevi Cataract & IOL Research Center | Ahmedabad | Gujarat |
Lead Sponsor | Collaborator |
---|---|
Iladevi Cataract and IOL Research Center |
India,
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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