Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

Status Completed

Clinical Trial Summary

The purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.

Clinical Trial Description

This is a post-market, prospective, non-significant risk, open-label, randomized multi-center clinical trial evaluating treatment with the LipiFlow System in patients with meibomian gland dysfunction prior to planned bilateral cataract surgery. All subjects undergo examination to determine study eligibility and to capture the Baseline status prior to surgery. Subjects are randomized to receive LipiFlow treatment (Pre-treatment group) one month before cataract surgery or no LipiFlow treatment (Untreated Control group). Cataract surgery is performed on both eyes of each subject with the second eye surgery completed within two months of the first eye. All subjects are evaluated at one month and three months after cataract surgery on the second eye with comparison of the study endpoints between the Pre-treatment and Untreated groups. To facilitate subject recruitment, the Untreated Control group receives crossover LipiFlow treatment for MGD (Post-treatment group) three months after cataract surgery on the second eye. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01808560
Study type	Interventional
Source	TearScience, Inc.
Contact
Status	Completed
Phase	N/A
Start date	March 2013
Completion date	January 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02597803` - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1	Phase 2/Phase 3
Completed	`NCT02522312` - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients	N/A
Completed	`NCT01863368` - Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining	N/A
Completed	`NCT01753752` - Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation	Phase 2
Completed	`NCT01753687` - Correlation of Different Signs for Assessment of Dry Eye Syndrome	N/A
Completed	`NCT01212471` - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease	Phase 3
Completed	`NCT01198782` - Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%	Phase 4
Completed	`NCT01162954` - Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers	Phase 1
Completed	`NCT00544713` - Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery	N/A
Completed	`NCT00535054` - Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms	N/A
Completed	`NCT00344721` - A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome	N/A
Completed	`NCT03830359` - Efficacy, Safety of T2769 in Dry Eye Disease	N/A
Completed	`NCT04139122` - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease	Phase 1/Phase 2
Completed	`NCT02758327` - Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops	Phase 4
Completed	`NCT02066051` - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD	N/A
Completed	`NCT01970917` - Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects	Phase 4
Completed	`NCT02092207` - Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT01541891` - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT01252121` - Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline	N/A
Completed	`NCT00765804` - Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye	Phase 2