Senile CataractNCT05014269
Phacoemulsification in Patients With Corneal Opacities
An observational study of Senile Cataract, run by Assiut University.
Trial summary
In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Senile Cataract
- What is being tested?
- Phacoemulsification in eyes with corneal opacities
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jul 2018
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with visually significant senile cataract and corneal opacities
Who may be able to join
- The presence of visually significant senile cataract.
- A recent history of progressive diminution of vision within few months.
- Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.
Who cannot join
- History of trauma, infectious corneal ulcers, or intraocular surgery.
- Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.
About this study
Official title: Phacoemulsification in Patients With Corneal Opacities Using Slit Illumination of the Surgical Microscope
In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed.
Read the detailed description
Corneal opacity is often encountered in patients seeking senile cataract surgery in developing countries. Corneal opacity impairs the intraoperative visualization during cataract surgery which increases the risk of copmlications.
Several techniques were described to enhance the intraoperative visualization such as the use of anterior endoscopy, chandeiler retroillumination, and anterior chamber endoillumination. All these techniques require costly instrumentation.
the aim of this study was to assess the feasibility of performing phacoemulsification using slit illumination of the surgical microscope without the need of additional instruments, and report the visual outcome.
- Conditions
- Senile Cataract
- Being tested
- Phacoemulsification in eyes with corneal opacities
- Keywords
- Senile Cataract, Corneal opacity, Phacoemulsification
- Medical subject headings
- Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification in eyes with corneal opacitiesProcedure or surgery
senile cataract extraction using lens emulsification under the slit illuimnation of the surgical microscope
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope.
the frequency of the intraoperative complications of phacoemulsification in eyes with corneal opacities
Measured: 3 months
Secondary outcomes (1)
Visual outcome of phacoemulsification in eyes with corneal opacities
meaurement of the change of the distance corrected visual acuity bafoer after phacoemulsification using Snellen chart
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Jan 2015
- Primary completion30 Dec 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile CataractStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud F. Rateb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014269
- Sponsor's protocol ID
- phacoemulsification surgery
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification in Patients With Corneal Opacities Using Slit Illumination of the Surgical Microscope
- ClinicalTrials.gov ID
- NCT05014269
- Acronym / sponsor ID
- phacoemulsification surgery
- Conditions
- Senile Cataract
- Keywords
- Senile Cataract, Corneal opacity, Phacoemulsification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 20 Aug 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.
In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed.
Detailed description
Corneal opacity is often encountered in patients seeking senile cataract surgery in developing countries. Corneal opacity impairs the intraoperative visualization during cataract surgery which increases the risk of copmlications.
Several techniques were described to enhance the intraoperative visualization such as the use of anterior endoscopy, chandeiler retroillumination, and anterior chamber endoillumination. All these techniques require costly instrumentation.
the aim of this study was to assess the feasibility of performing phacoemulsification using slit illumination of the surgical microscope without the need of additional instruments, and report the visual outcome.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with visually significant senile cataract and corneal opacities
Key inclusion criteria (3 listed)
- The presence of visually significant senile cataract.
- A recent history of progressive diminution of vision within few months.
- Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.
Key exclusion criteria (2 listed)
- History of trauma, infectious corneal ulcers, or intraocular surgery.
- Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.
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 |
|---|---|---|
| Phacoemulsification in eyes with corneal opacitiessenile cataract extraction using lens emulsification under the slit illuimnation of the surgical microscope | Procedure or surgery | – |
Primary outcome
The rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope.
Time frame: 3 months
the frequency of the intraoperative complications of phacoemulsification in eyes with corneal opacities
1 secondary outcome
Visual outcome of phacoemulsification in eyes with corneal opacities
Time frame: 3 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 20 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Senile Cataract, run by Assiut University.
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 3 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope. (time frame: 3 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 20 Aug 2021.