Clinical Outcomes About Heparin Surface Modified Aspheric Lens

Inflammatory Reaction Clinical Trial

Official title:

Clinical Outcomes About Heparin Surface Modified Aspheric Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026765
• Other study ID #: 5AT-6M
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 8, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cataract patients

Exclusion Criteria:

• Eyed patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Reaction

Intervention

Device:
• traditional lens
A random eyes with traditional lens
• heparin surface modified aspheric lens
the other eye implant heparin surface modified aspheric lens

Locations

Country	Name	City	State
China	The Affiliated Eye hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No