Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

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Bausch + Lomb

Status and phase

Completed
Phase 4

Conditions

Cataract
Aphakia

Treatments

Procedure: Coaxial Small Incision Cataract Surgery
Procedure: Coaxial Micro-Incision Cataract Surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT01261975
607

Details and patient eligibility

About

The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.

Enrollment

36 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
  • Subject's ocular media must be clear except for the presence of the cataract in both eyes.

Exclusion criteria

Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Coaxial Micro-Incision Cataract Surgery
Experimental group
Description:
1.8 mm coaxial microincision
Treatment:
Procedure: Coaxial Micro-Incision Cataract Surgery
Coaxial Small Incision Cataract Surgery
Active Comparator group
Description:
2.75 mm standard incision
Treatment:
Procedure: Coaxial Small Incision Cataract Surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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