Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03817151
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Actual Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.

Condition or Disease	Intervention/Treatment	Phase
Absence of Capsule Support; Aphakia	Procedure: posterior chamber intraocular lens implantation

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. Visual function [1day postoperation]

   Best corrected visual acuity (BCVA) measured using a decimal chart

2. Visual function [1 week postoperation]

   Best corrected visual acuity (BCVA) measured using a decimal chart

3. Visual function [1 month postoperation]

   Best corrected visual acuity (BCVA) measured using a decimal chart

4. Visual function [3 month postoperation]

   Best corrected visual acuity (BCVA) measured using a decimal chart

5. Visual function [1 day postoperation]

   uncorrected distance visual acuity (UDVA) measured using a decimal chart

6. Visual function [1 week postoperation]

   uncorrected distance visual acuity (UDVA) measured using a decimal chart

7. Visual function [1 month postoperation]

   uncorrected distance visual acuity (UDVA) measured using a decimal chart

8. Visual function [3 month postoperation]

   uncorrected distance visual acuity (UDVA) measured using a decimal chart

Secondary Outcome Measures

1. intraocular pressure [1 day, 1 week, 1 month, and 3 month postoperation]

   intraocular pressure

2. PCIOL tilt degree [3 month postoperation]

   PCIOL tilt degree measured using Ultrasound biomicroscope

3. PCIOL decentration degree [3 month postoperation]

   PCIOL tilt degree measured using Ultrasound biomicroscope

4. endothelial cell count [1 week, 1 month, and 3 month postoperation]

   endothelial cell count

5. anterior chamber depth [3 month postoperation]

   anterior chamber depth measured using Ultrasound biomicroscope

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients who underwent transscleral suture fixation of PCIOL

2. Time between the primary surgeries was at least 3 months

Exclusion Criteria:

1. Active intraocular inflammation

2. The intraocular pressure (IOP) was higher than 25 mmHg

3. The endothelial cell count (ECC) was more than 1,200 cells/mm2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT03817151
• Other Study ID Numbers: xuwen2017-022
• First Posted: Jan 25, 2019
• Last Update Posted: Jan 25, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aphakia

Study Results

No Results Posted as of Jan 25, 2019