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Completed

NCT Number: NCT03587909

FLACS vs Phaco in Shallow Anterior Chamber

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?

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Key information

Conditions

Cataract Surgery Phacoemulsification Shallow Anterior Chamber

Age range

30 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iladevi Cataract & IOL Research Center

Ahmedabad, Gujarat, 380052, India

About this study

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:

  • 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).
  • 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
  • Other Observations :
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Coexisting ocular morbidity,
  • inability to come for followup

Treatment and study plan

Phacoemulsification Cataract Surgery

Procedure

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

Femtosecond Cataract Surgery

Procedure

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

Primary outcomes

  1. Central Corneal Thickness

    Time frame: Postoperative Day 1

    Central Corneal Thickness

Secondary outcomes

  1. Anterior Chamber Inflammation

    Time frame: Postoperative Day 1

    Anterior chamber cells and flare (Hogan's criteria)

  2. Endothelial Cell Morphology

    Time frame: Postoperative 6 months

    Endothelial Cell Density

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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