Completed

NCT Number: NCT01664689

Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

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

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Key information

Conditions

Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380052, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microcoaxial Phacoemulsification

Procedure

Primary outcomes

Corneal clarity on postoperative day 1

Time frame: postoperative day 1

Secondary outcomes

Central corneal thickness on postoperative day 1 and week 1

Time frame: day 1 and week 1

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Aug 14, 2012
Registry last updated: Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.