Aurolab Hydrophobic Foldable Intraocular Lens Study

• Sponsor: Aurolab (Other)
• Overall Status: Completed
• CT.gov ID: NCT00449267
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 13.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Intraocular Lens	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Device: Intraocular Lens; Phacoemulsification with in the bag implantation of the IOL; Other Names: Aurovue, Model HP757SQ

Outcome Measures

Primary Outcome Measures

1. Visual acuity [10days, 40 days, 150 days post operatively]

Secondary Outcome Measures

1. Refraction [10days, 40 days, 150 days post operatively]

2. Intraocular pressure [10days, 40 days, 150 days post operatively]

3. Corneal status [10days, 40 days, 150 days post operatively]

4. Iritis [10days, 40 days, 150 days post operatively]

5. IOL decentration [10days, 40 days, 150 days post operatively]

6. IOL tilt [10days, 40 days, 150 days post operatively]

7. IOL discoloration [10days, 40 days, 150 days post operatively]

8. IOL opacity [10days, 40 days, 150 days post operatively]

9. Cystoid macular oedema [10days, 40 days, 150 days post operatively]

10. Hypopyon [10days, 40 days, 150 days post operatively]

11. Endophthalmitis [10days, 40 days, 150 days post operatively]

12. Pupillary block [10days, 40 days, 150 days post operatively]

13. Retinal detachment [10days, 40 days, 150 days post operatively]

14. Status of anterior and posterior capsule [10days, 40 days, 150 days post operatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aravind Eye Hospital	Madurai	Tamil Nadu	India	625020

Sponsors and Collaborators

• Aurolab

Investigators

• Principal Investigator: Haripriya Aravind, MBBS, MS, Aravind Eye Hospital, Madurai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00449267
• Other Study ID Numbers: 1PN1010614
• First Posted: Mar 20, 2007
• Last Update Posted: Feb 11, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Lenses, Intraocular; Prospective Studies; Visual acuity; Clinical Trial
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Feb 11, 2009