Pediatric CataractNCT05278936
New Technique in Congenital/Pediatric Cataract Surgery
A study testing The cataract surgery and the anterior vitrectomy in people with Pediatric Cataract and Congenital Cataract, run by Omer Othman Abdullah at 1 site in Iraq.
Trial summary
In pediatric/congenital cataract surgery; multiple surgical interventions are performed, which needs multiple general anesthesias. Here, we describe a new technique, to end the operation in one session. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Cataract, Congenital Cataract
- What is being tested?
- The cataract surgery and the anterior vitrectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2021to 1 Oct 2021
- 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
- Congenital/pediatric cataract
Who cannot join
- Aphakic and pseudophakic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Simplified Sclerocorneal Incision/Tunnel in Performing Congenital/Pediatric Cataract Surgery
In pediatric/congenital cataract surgery; multiple surgical interventions are performed, which needs multiple general anesthesias. Here, we describe a new technique, to end the operation in one session.
Read the detailed description
Generally, in congenital/pediatric cataract surgery, it might be possible to different multiple procedures with multiple general anesthesias. Here, the investigators found a new procedure to perform the cataract removal, intraocular implantation, and the anterior vitrectomy all in one session through a sclero-corneal tunnel. The corneoscleral tunnels are covered by the conjunctiva to abolish the need for both suturing and repeated general anesthesia to remove corneal sutures.
- Conditions
- Pediatric Cataract, Congenital Cataract
- Being tested
- The cataract surgery and the anterior vitrectomy
- Keywords
- Corneoscleral incision, Cataract surgery, Vitreorrhexis, Anterior vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cataract surgery and the anterior vitrectomyOther
Surgical
| Study group | Role | What they receive |
|---|---|---|
| A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery | Other | Participitant Receives: Other: The cataract surgery and the anterior vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit-lamp examination
To check the intra-ocular lens positioning
Measured: The fourth weeks postoperatively
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 2021
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CataractStudies 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
- 52 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 CenterHuseyin Oksuz, MD, Study director, Dunya Goz Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278936
- Sponsor's protocol ID
- IMER 1
- Status last verified
- Apr 2022
- First submitted
- 23 Feb 2022
- Last updated
- 2 May 2022
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simplified Sclerocorneal Incision/Tunnel in Performing Congenital/Pediatric Cataract Surgery
- ClinicalTrials.gov ID
- NCT05278936
- Acronym / sponsor ID
- IMER 1
- Conditions
- Pediatric Cataract, Congenital Cataract
- Keywords
- Corneoscleral incision, Cataract surgery, Vitreorrhexis, Anterior vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Omer Othman AbdullahUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (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.
In pediatric/congenital cataract surgery; multiple surgical interventions are performed, which needs multiple general anesthesias. Here, we describe a new technique, to end the operation in one session.
Detailed description
Generally, in congenital/pediatric cataract surgery, it might be possible to different multiple procedures with multiple general anesthesias. Here, the investigators found a new procedure to perform the cataract removal, intraocular implantation, and the anterior vitrectomy all in one session through a sclero-corneal tunnel. The corneoscleral tunnels are covered by the conjunctiva to abolish the need for both suturing and repeated general anesthesia to remove corneal sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery | Other | Other: The cataract surgery and the anterior vitrectomyParticipitant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Congenital/pediatric cataract
Key exclusion criteria (1 listed)
- Aphakic and pseudophakic
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 cataract surgery and the anterior vitrectomySurgical | Other | A simplified sclero-cornel tunnel/incision in performing the congenital/pediatric cataract surgery |
Primary outcome
Slit-lamp examination
Time frame: The fourth weeks postoperatively
To check the intra-ocular lens positioning
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 2 May 2022.
- Individual participant dataSharing planned: No
Related trials for Pediatric Cataract
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The Effect of Vascular Imaging Devices on Success Rates of Peripheral Vascular Access in Pediatric Patients
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Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery
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Shanghai Pediatric Cataract Study
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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
Huseyin Oksuz, MD study director
Dunya Goz Hospital
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 cataract surgery and the anterior vitrectomy in people with Pediatric Cataract and Congenital Cataract, 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 1 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 2 May 2022. 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?
Slit-lamp examination (time frame: The fourth weeks postoperatively). 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 2 May 2022.