Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

March 23, 2023 updated by: Omer Othman Abdullah

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Erbil, Iraq, 44001
        • Ibinsina Modern Eye and Retina Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dislocated primary scleral fixed IOL

Exclusion Criteria:

  • Iris claw IOL
  • Anterior chamber IOL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The slit-lamp examination.
Time Frame: 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).
The fourth week post-operatively.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omer Othman Abdullah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

March 21, 2023

Study Completion (Actual)

March 21, 2023

Study Registration Dates

First Submitted

February 19, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMER 14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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