Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

Sponsor

Omer Othman Abdullah (Other)

Overall Status

Recruiting

CT.gov ID

NCT05278949

Collaborator

(none)

Enrollment

Location

Arm

8.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Lens Complication	Other: The surgical intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Novel Technique of Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: The scleral pocket for the primary implanted IOL single arm	Other: The surgical intervention The participant's primary IOL is re-fixed without utilizing any new material.

Arm

Intervention/Treatment

Other: The scleral pocket for the primary implanted IOL

single arm

Other: The surgical intervention

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

Outcome Measures

Primary Outcome Measures

The slit-lamp examination. [The fourth week post-operatively.]
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).

Secondary Outcome Measures

The visual acuity. [The fourth week post-operatively.]
To assess both the uncorrected and the best corrected visual acuity ( with glasses).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Dislocated primary scleral fixed IOL

Exclusion Criteria:

Iris claw IOL
Anterior chamber IOL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ibinsina Modern eye and retina center	Erbil		Iraq	44001

Sponsors and Collaborators

Omer Othman Abdullah

Investigators

Principal Investigator: Omer Abdullah, M.Sc., Ibinsina Modern Eye and Retina Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina Center

ClinicalTrials.gov Identifier:

NCT05278949

Other Study ID Numbers:

IMER 14

First Posted:

Mar 14, 2022

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina Center

Intraocular lens dislocation

Scleral re-fixation

scleral fixation

Additional relevant MeSH terms:

Joint Dislocations

Study Results

No Results Posted as of Aug 3, 2022