Outcome of Stepped Cataract Surgery in UveitisNCT04931277
Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye
A study testing cataract surgery in people with Outcome of Stepped Cataract Surgery in Uveitis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome of Stepped Cataract Surgery in Uveitis
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2021to 30 May 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
- the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement
Who cannot join
- the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.
- Being tested
- cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
stepped surgery in the form of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.
| Study group | Role | What they receive |
|---|---|---|
| stepped cataract surgery | Other | Not described Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visulal acuity
overall improvement in vision using LogMAR
Measured: 6 months
Secondary outcomes (1)
Intraocular inflammation
flare up of inflammation after surgery USING SUN classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Feb 2021
- Primary completion15 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome of Stepped Cataract Surgery in UveitisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amgad Mahmoud El Nokrashy, Mansoura University
- Investigators
- Amgad El Nokrashy, MD, Principal investigator, Mansoura UniversityDina Abd El Fattah, MD, Study chair, Mansoura UniversityRania Bassiouny, MD, Study chair, Mansoura UniversityShreen Gaafar, MD, Study chair, Mansoura UniversityWaleed Gaafar, MD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931277
- Sponsor's protocol ID
- R.21.01.1176
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye
- ClinicalTrials.gov ID
- NCT04931277
- Acronym / sponsor ID
- R.21.01.1176
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 18 Jun 2021 (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.
This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stepped cataract surgery | Other | Procedure: cataract surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement
Key exclusion criteria (1 listed)
- the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis
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 |
|---|---|---|
| cataract surgerystepped surgery in the form of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis. | Procedure or surgery | stepped cataract surgery |
Primary outcome
Visulal acuity
Time frame: 6 months
overall improvement in vision using LogMAR
1 secondary outcome
Intraocular inflammation
Time frame: 6 months
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 23 Jun 2021.
- Individual participant dataSharing planned: No. results
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.
Amgad El Nokrashy, MD principal investigator
Mansoura University
Dina Abd El Fattah, MD study chair
Mansoura University
Rania Bassiouny, MD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Outcome of Stepped Cataract Surgery in Uveitis, run by Mansoura University at 1 site in Egypt.
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 23 Jun 2021. 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 Egypt. 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?
Visulal acuity (time frame: 6 months). 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 23 Jun 2021.