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Aurolab Hydrophobic Foldable Intraocular Lens Study

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Intraocular Lens

About this trial

This is an interventional treatment trial for Cataract focused on measuring Lenses, Intraocular, Prospective Studies, Visual acuity, Clinical Trial

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aravind Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Refraction

Intraocular pressure

Corneal status

Iritis

IOL decentration

IOL tilt

IOL discoloration

IOL opacity

Cystoid macular oedema

Hypopyon

Endophthalmitis

Pupillary block

Retinal detachment

Status of anterior and posterior capsule

Full Information

NCT ID

NCT00449267

First Posted

March 17, 2007

Last Updated

February 10, 2009

Sponsor

Aurolab

1. Study Identification

Unique Protocol Identification Number

NCT00449267

Brief Title

Aurolab Hydrophobic Foldable Intraocular Lens Study

Official Title

Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Aurolab

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Lenses, Intraocular, Prospective Studies, Visual acuity, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Intraocular Lens

Other Intervention Name(s)

Aurovue, Model HP757SQ

Intervention Description

Phacoemulsification with in the bag implantation of the IOL

Primary Outcome Measure Information:

Title

Visual acuity

Time Frame