NCT05278949

Brief Summary

To minimize multiple manipulations and to decrease the economical burden; here, we describe how to utilize the patient's own dislocated intraocular lens to re-fixate with the sclera.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

February 19, 2022

Last Update Submit

March 23, 2023

Conditions

Intraocular Lens Complication

Keywords

Intraocular lens dislocationScleral re-fixationscleral fixation

Outcome Measures

Primary Outcomes (1)

  • The slit-lamp examination.

    To assess the intra-ocular pressure mmHg, the re-fixated intraocular lens position ( central, tilted or displaced),and leakage from the incisions, and the hemorrhage ( whether in the anterior segment or in the posterior segment).

    The fourth week post-operatively.

Secondary Outcomes (1)

  • The visual acuity.

    The fourth week post-operatively.

Study Arms (1)

The scleral pocket for the primary implanted IOL

OTHER

single arm

Other: The surgical intervention

Interventions

The surgical interventionOTHER

The participant's primary IOL is re-fixed without utilizing any new material.

The scleral pocket for the primary implanted IOL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dislocated primary scleral fixed IOL

You may not qualify if:

  • Iris claw IOL
  • Anterior chamber IOL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibinsina Modern eye and retina center

Erbil, 44001, Iraq

Location

Study Officials

  • Omer Abdullah, M.Sc.

    Ibinsina Modern Eye and Retina Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate consultant ophthalmologist

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 14, 2022

Study Start

January 1, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)