Aurolab Hydrophobic Foldable Intraocular Lens Study

NCT ID: NCT00449267

Last Updated: 2009-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.

Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Intraocular Lens

Intervention Type DEVICE

Phacoemulsification with in the bag implantation of the IOL

Interventions

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Intraocular Lens

Phacoemulsification with in the bag implantation of the IOL

Intervention Type DEVICE

Other Intervention Names

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Aurovue, Model HP757SQ

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
* Corneal Pathology
* Retinal Pathology
* Intra operative complications like PC rupture, Zonular dialysis
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Aravind Eye Hospital

Principal Investigators

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Haripriya Aravind, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Aravind Eye Hospital, Madurai

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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1PN1010614

Identifier Type: -

Identifier Source: org_study_id

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