Aurolab Hydrophobic Foldable Intraocular Lens Study

Aurolab

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Intraocular Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT00449267

1PN1010614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

1

Experimental group

Treatment:

Device: Intraocular Lens