Re-fixating Dislocated Scleral Fixing Intra-ocular Lens | NCT05278949

Studies
Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

NCT05278949

Sponsor

Omer Othman Abdullah

Status

Completed

Last Update Posted

Mar 24, 2023Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Intraocular Lens Complication

Interventions

The surgical intervention

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Mar 21, 2023Actual

Completion Date

Mar 21, 2023Actual

First Submitted Date

Feb 19, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina CenterSponsor-Investigator

Lead Sponsor

Omer Othman AbdullahOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

When a scleral fixated intraocular lens (IOL) is displaced; routinely it is extracted and exchanged with another IOL and re-fixated to the sclera or another modality can be used. Both can carry many complications due to multiple manipulations. Nevertheless, suture and/or haptic end exposure is another expected future complication, which can range from foreign body sensation to endophthalmitis.

Here, the investigators utilized the same participant's IOL with minimum manipulations and the haptic ends buried inside scleral pockets to prevent future exposure and complications. The pocket entry is sutured with 8/0 vicryl, which is absorbable, to overcome complications.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The scleral pocket for the primary implanted IOL	Other	single arm	Other: The surgical intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The surgical intervention	Other	The participant's primary IOL is re-fixed without utilizing any new material.	The scleral pocket for the primary implanted IOL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The visual acuity.	To assess both the uncorrected and the best corrected visual acuity ( with glasses).	The fourth week post-operatively.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dislocated primary scleral fixed IOL

Exclusion Criteria:

Iris claw IOL
Anterior chamber IOL

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer Abdullah, M.Sc.	Ibinsina Modern Eye and Retina Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ibinsina Modern eye and retina center		Erbil		44001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided