Clinical Outcomes About Heparin Surface Modified Aspheric Lens

• Sponsor: Wenzhou Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02026765
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Reaction	Device: traditional lens; Device: heparin surface modified aspheric lens	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes About Heparin Surface Modified Aspheric Lens
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Heparin Surface Modified Aspheric Lens 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

Outcome Measures

Primary Outcome Measures

1. flare value in the anterior chamber after surgery [six months]

   use Laser Flare Meter to measure the flare in the anterior chamber to evaluate postoperative ocular inflammatory reaction

Secondary Outcome Measures

1. the ocular and the anterior corneal aberration after surgery [six months]

   use wavefront aberrometer to measure the ocular and the anterior corneal aberration to evaluate postoperative ocular optical quality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cataract patients

Exclusion Criteria:

• Eyed patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Eye hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

• Wenzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: A-Yong Yu, Dr, Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT02026765
• Other Study ID Numbers: 5AT-6M
• First Posted: Jan 3, 2014
• Last Update Posted: Dec 9, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Inflammation; Heparin

Study Results

No Results Posted as of Dec 9, 2015