Aurolab Hydrophobic Foldable Intraocular Lens Study

Cataract Clinical Trial

Official title:

Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449267
• Other study ID #: 1PN1010614
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2007
• Last updated: February 10, 2009
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Intraocular Lens
Phacoemulsification with in the bag implantation of the IOL

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		10days, 40 days, 150 days post operatively	No
Secondary	Refraction		10days, 40 days, 150 days post operatively	No
Secondary	Intraocular pressure		10days, 40 days, 150 days post operatively	Yes
Secondary	Corneal status		10days, 40 days, 150 days post operatively	Yes
Secondary	Iritis		10days, 40 days, 150 days post operatively	Yes
Secondary	IOL decentration		10days, 40 days, 150 days post operatively	No
Secondary	IOL tilt		10days, 40 days, 150 days post operatively	No
Secondary	IOL discoloration		10days, 40 days, 150 days post operatively	No
Secondary	IOL opacity		10days, 40 days, 150 days post operatively	No
Secondary	Cystoid macular oedema		10days, 40 days, 150 days post operatively	Yes
Secondary	Hypopyon		10days, 40 days, 150 days post operatively	Yes
Secondary	Endophthalmitis		10days, 40 days, 150 days post operatively	Yes
Secondary	Pupillary block		10days, 40 days, 150 days post operatively	Yes
Secondary	Retinal detachment		10days, 40 days, 150 days post operatively	Yes
Secondary	Status of anterior and posterior capsule		10days, 40 days, 150 days post operatively	No