NCT05834465

Brief Summary

Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

March 24, 2023

Last Update Submit

June 27, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • The position of IOL through tilt (tilt in degree)

    Evaluation of the position of IOL through tilt (tilt in degree)

    Two hours after cataract surgery (i.e. before anterior chamber drainage)

  • The position of IOL through decentration (decentration in millimeter)

    Evaluation of the position of IOL through decentration (decentration in millimeter)

    Two hours after cataract surgery (i.e. before anterior chamber drainage)

  • The position of IOL through tilt (tilt in degree)

    Evaluation of the position of IOL through tilt (tilt in degree)

    Immediately after anterior chamber drainage

  • The position of IOL through decentration (decentration in millimeter)

    Evaluation of the position of IOL through decentration (decentration in millimeter)

    Immediately after anterior chamber drainage

Study Arms (3)

Group 1

After using a non-contact tonometer to measure, the intraocular pressure is reduced by 0-10mmHg.

Group 2

After using a non-contact tonometer to measure, the intraocular pressure is reduced by 10-20mmHg.

Group 3

After using a non-contact tonometer to measure, the intraocular pressure is reduced over 20mmHg.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation" 2 hours after using a non-contact tonometer (FT-1000, TOMEY, JAPAN) to check that the intraocular pressure exceeds 28mmHg accompanied by corneal edema, anterior chamber radiation and age-related cataract patients over 60 years of age is required.

You may qualify if:

  • Patients over 60 years old who underwent simple age-related cataract surgery in Eye Hospital of Wenzhou Medical University, the operation was successful, and there were no intraoperative complications such as posterior capsule rupture;
  • Measurements were taken before and after drainage, and all data were complete ;
  • The patient agrees and accepts the study.

You may not qualify if:

  • Preoperative glaucoma, ocular hypertension, iritis, uveitis and other eye diseases, as well as other eye diseases and serious systemic diseases that may affect the prognosis of surgery, such as corneal lesions, vitreous volume blood, retinal detachment, poor blood sugar control in diabetes, etc.
  • Previous history of eye trauma, etc.
  • Cannot cooperate with the completion of intraocular pressure measurement and CASIA2 examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Pingjun Chang

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 28, 2023

Study Start

July 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations