Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

Iladevi Cataract and IOL Research Center

Status: Completed

Conditions: Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Treatments: Procedure: Microcoaxial Phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01664689

OVD12

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

DiscoVisc

Active Comparator group

Description:

microcoaxial phacoemulsification performed with discovisc

Treatment:

Procedure: Microcoaxial Phacoemulsification

Healon 5

Active Comparator group

Description:

microcoaxial phacoemulsification using healon 5

Treatment:

Procedure: Microcoaxial Phacoemulsification

Celoftal

Active Comparator group

Description:

microcoaxial phacoemulsification using celoftal

Treatment:

Procedure: Microcoaxial Phacoemulsification