Clinical trial NCT03587909: FLACS vs Phaco in Shallow Anterior Chamber
Official title: Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Shallow Anterior Chamber
Phacoemulsification
Keywords: FLACS
Phaco
Shallow Anterior Chamber
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 91
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Central Corneal Thickness
timeFrame: Postoperative Day 1
Secondary outcomes:
measure: Anterior Chamber Inflammation
timeFrame: Postoperative Day 1
measure: Endothelial Cell Morphology
timeFrame: Postoperative 6 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Iladevi Cataract & IOL Research Center
state: Gujarat
Study officials:
affiliation: Iladevi Cataract & IOL Research Centre, Ahmedabad
name: Abhay Vasavada, MS,FRCS
role: PRINCIPAL_INVESTIGATOR
References: