Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

• Sponsor: Iladevi Cataract and IOL Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01664689
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 24

Study Details

Study Description

Brief Summary

Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery	Procedure: Microcoaxial Phacoemulsification	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DiscoVisc microcoaxial phacoemulsification performed with discovisc	Procedure: Microcoaxial Phacoemulsification
Active Comparator: Healon 5 microcoaxial phacoemulsification using healon 5	Procedure: Microcoaxial Phacoemulsification
Active Comparator: Celoftal microcoaxial phacoemulsification using celoftal	Procedure: Microcoaxial Phacoemulsification

Outcome Measures

Primary Outcome Measures

1. Corneal clarity on postoperative day 1 [postoperative day 1]

Secondary Outcome Measures

1. Central corneal thickness on postoperative day 1 and week 1 [day 1 and week 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age related, uncomplicated senile cataracts

Exclusion Criteria:

• presence of glaucoma,

• shallow anterior chamber (ACD < 2.1mm),

• pupillary dilatation < 6mm,

• extremely dense cataracts,

• posterior polar cataract,

• subluxated cataract,

• white mature cataract,

• diabetic retinopathy,

• high myopia (defined as AL > 25mm),

• uveitis, or

• previous ocular trauma/surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iladevi Cataract & IOL Research Centre	Ahmedabad	Gujarat	India	380052

Sponsors and Collaborators

• Iladevi Cataract and IOL Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iladevi Cataract and IOL Research Center
• ClinicalTrials.gov Identifier: NCT01664689
• Other Study ID Numbers: OVD12
• First Posted: Aug 14, 2012
• Last Update Posted: Aug 14, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Aug 14, 2012