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

Aphakia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817151
• Other study ID #: xuwen2017-022
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Absence of Capsule Support
• Aphakia

Intervention

Procedure:
• posterior chamber intraocular lens implantation
patients who underwent transscleral sutured posterior chamber intraocular lens implantation

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	1day postoperation
Primary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	1 week postoperation
Primary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	1 month postoperation
Primary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart	3 month postoperation
Primary	Visual function	uncorrected distance visual acuity (UDVA) measured using a decimal chart	1 day postoperation
Primary	Visual function	uncorrected distance visual acuity (UDVA) measured using a decimal chart	1 week postoperation
Primary	Visual function	uncorrected distance visual acuity (UDVA) measured using a decimal chart	1 month postoperation
Primary	Visual function	uncorrected distance visual acuity (UDVA) measured using a decimal chart	3 month postoperation
Secondary	intraocular pressure	intraocular pressure	1 day, 1 week, 1 month, and 3 month postoperation
Secondary	PCIOL tilt degree	PCIOL tilt degree measured using Ultrasound biomicroscope	3 month postoperation
Secondary	PCIOL decentration degree	PCIOL tilt degree measured using Ultrasound biomicroscope	3 month postoperation
Secondary	endothelial cell count	endothelial cell count	1 week, 1 month, and 3 month postoperation
Secondary	anterior chamber depth	anterior chamber depth measured using Ultrasound biomicroscope	3 month postoperation