Endothelial Cell Loss After Cataract Surgery

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Cataracts

Treatments: Procedure: Reduced ultrasound phacoemulsification; Procedure: Standard phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT00932191

DHCrush001

Details and patient eligibility

About

The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.

Enrollment: 39 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visually significant moderate density cataract

Exclusion criteria

• Corneal or retinal pathology limiting visual potential to worse than 20/40
• Lens pathology including pseudoexfoliation or lens dislocation
• Prior intraocular surgery
• Age less than 40

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Ultrasound phacoemulsification

Active Comparator group

Description:

Cataract nucleus is removed using standard amounts of ultrasound energy.

Treatment:

Procedure: Standard phacoemulsification

Reduced ultrasound phacoemulsification

Active Comparator group

Description:

Cataract nucleus removal using less ultrasound energy and more mechanical energy.

Treatment:

Procedure: Reduced ultrasound phacoemulsification