NCT00449267

Brief Summary

The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

March 17, 2007

Last Update Submit

February 10, 2009

Conditions

Cataract

Keywords

Lenses, IntraocularProspective StudiesVisual acuityClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    10days, 40 days, 150 days post operatively

Secondary Outcomes (14)

  • Refraction

    10days, 40 days, 150 days post operatively

  • Intraocular pressure

    10days, 40 days, 150 days post operatively

  • Corneal status

    10days, 40 days, 150 days post operatively

  • Iritis

    10days, 40 days, 150 days post operatively

  • IOL decentration

    10days, 40 days, 150 days post operatively

  • +9 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Device: Intraocular Lens

Interventions

Intraocular LensDEVICE

Phacoemulsification with in the bag implantation of the IOL

Also known as: Aurovue, Model HP757SQ
1

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 65 years
  • Senile Cataract
  • Posterior Subcapsular Cataract (PSCC)

You may not qualify if:

  • Obviously debilitated patients
  • Cardiac and other serious illness
  • Diabetic Patients
  • Traumatic cataract
  • Complicated cataract
  • Congenital cataract
  • Drug induced cataract
  • Shallow anterior chamber
  • Poor mydriasis
  • Amblyopia
  • Pseudo exfoliation (PXF)
  • Dense posterior polar cataract (PPC)
  • One eyed patients
  • Glaucoma
  • Uveitis
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

Location

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Haripriya Aravind, MBBS, MS

    Aravind Eye Hospital, Madurai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2007

First Posted

March 20, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

IN(1)