Intraocular Lens ComplicationNCT05278949
Re-fixating Dislocated Scleral Fixing Intra-ocular Lens
A study testing The surgical intervention in people with Intraocular Lens Complication, run by Omer Othman Abdullah at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraocular Lens Complication
- What is being tested?
- The surgical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2022to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dislocated primary scleral fixed IOL
Who cannot join
- Iris claw IOL
- Anterior chamber IOL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Lens Complication
- Being tested
- The surgical intervention
- Keywords
- Intraocular lens dislocation, Scleral re-fixation, scleral fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The surgical interventionOther
The participant's primary IOL is re-fixed without utilizing any new material.
| Study group | Role | What they receive |
|---|---|---|
| The scleral pocket for the primary implanted IOL | Other | single arm Receives: Other: The surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The fourth week post-operatively.
Secondary outcomes (1)
The visual acuity.
To assess both the uncorrected and the best corrected visual acuity ( with glasses).
Measured: The fourth week post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jan 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omer Othman Abdullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omer Othman Abdullah, Ibinsina Modern Eye and Retina Center
- Investigators
- Omer Abdullah, M.Sc., Principal investigator, Ibinsina Modern Eye and Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278949
- Sponsor's protocol ID
- IMER 14
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique of Re-fixating Dislocated Scleral Fixing Intra-ocular Lens
- ClinicalTrials.gov ID
- NCT05278949
- Acronym / sponsor ID
- IMER 14
- Conditions
- Intraocular Lens Complication
- Keywords
- Intraocular lens dislocation, Scleral re-fixation, scleral fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Omer Othman AbdullahUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The scleral pocket for the primary implanted IOL | Other | Other: The surgical interventionsingle arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Dislocated primary scleral fixed IOL
Key exclusion criteria (2 listed)
- Iris claw IOL
- Anterior chamber IOL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The surgical interventionThe participant's primary IOL is re-fixed without utilizing any new material. | Other | The scleral pocket for the primary implanted IOL |
Primary outcome
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).
1 secondary outcome
The visual acuity.
Time frame: The fourth week post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Abdullah, M.Sc. principal investigator
Ibinsina Modern Eye and Retina Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The surgical intervention in people with Intraocular Lens Complication, run by Omer Othman Abdullah at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The slit-lamp examination. (time frame: The fourth week post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.