Clinical Outcomes About Heparin Surface Modified Aspheric Lens

The purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.

Study Overview

• Status: Completed
• Conditions: Inflammatory Reaction
• Intervention / Treatment: Device: heparin surface modified aspheric lens; Device: traditional lens

Detailed Description

1. Heparin surface treatment lens can reduce inflammatory reaction.
2. Modified aspheric lens are more in line with human optical properties than the traditional aspheric lens.
3. To obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.
4. After one day, one week, one month, three month follow-up，Key observation on the flare, the optical quality, contrast sensitivity and other parameters.Study the postoperative inflammatory reaction with test group lens，and the impact on the visual quality.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The Affiliated Eye Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cataract patients

Exclusion Criteria:

• Eyed patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Heparin Surface Modified Aspheric Lens	Device: heparin surface modified aspheric lens; the other eye implant heparin surface modified aspheric lens
Other: traditional lens; traditional Aspheric lens	Device: traditional lens; A random eyes with traditional lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
flare value in the anterior chamber after surgery	use Laser Flare Meter to measure the flare in the anterior chamber to evaluate postoperative ocular inflammatory reaction	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the ocular and the anterior corneal aberration after surgery	use wavefront aberrometer to measure the ocular and the anterior corneal aberration to evaluate postoperative ocular optical quality	six months

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Study Director: AYong Yu, MD. PhD., Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: January 1, 2014
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 5AT-6M