Cataract SenileNCT04220138
Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex
A study testing Anterior chamber illumination in cataract surgery in people with Cataract Senile, run by University of Alexandria at 1 site in Egypt.
Trial summary
With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Anterior chamber illumination in cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract with poor red reflex
Who cannot join
- Eyes that had previous intraocular surgery or trauma were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.
Read the detailed description
Several surgical techniques have been used to alleviate the problem of poor lens visibility. fixed a chandelier illuminator on the sclera, turned off the microscope light source, and visualized the lens by illuminating the vitreous cavity. Furino improved anterior lens capsule visibility by staining it with triamcinolone acetonide. Although both techniques were effective, both had limitations. Vitreous chamber illumination reduces the visibility of the cornea and iris because of the need to turn off the microscope light. Staining the anterior lens capsule with triamcinolone acetonide allows for better anterior chamber visualization but the lenticular nucleus and cortex remain difficult to see.
This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.
- Conditions
- Cataract Senile
- Being tested
- Anterior chamber illumination in cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior chamber illumination in cataract surgeryProcedure or surgery
This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.
| Study group | Role | What they receive |
|---|---|---|
| cataract patients with poor red reflex | Other | included cataract patients with poor red reflex Receives: Procedure: Anterior chamber illumination in cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abouhussein, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220138
- Sponsor's protocol ID
- 31248
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data of the patients are available to other researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex
- ClinicalTrials.gov ID
- NCT04220138
- Acronym / sponsor ID
- 31248
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 7 Jan 2020 (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.
With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.
Detailed description
Several surgical techniques have been used to alleviate the problem of poor lens visibility. fixed a chandelier illuminator on the sclera, turned off the microscope light source, and visualized the lens by illuminating the vitreous cavity. Furino improved anterior lens capsule visibility by staining it with triamcinolone acetonide. Although both techniques were effective, both had limitations. Vitreous chamber illumination reduces the visibility of the cornea and iris because of the need to turn off the microscope light. Staining the anterior lens capsule with triamcinolone acetonide allows for better anterior chamber visualization but the lenticular nucleus and cortex remain difficult to see.
This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cataract patients with poor red reflex | Other | Procedure: Anterior chamber illumination in cataract surgeryincluded cataract patients with poor red reflex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cataract with poor red reflex
Key exclusion criteria (1 listed)
- Eyes that had previous intraocular surgery or trauma were excluded.
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 |
|---|---|---|
| Anterior chamber illumination in cataract surgeryThis will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex. | Procedure or surgery | cataract patients with poor red reflex |
Primary outcome
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
Time frame: intraoperative
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
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 9 Jan 2020.
- Individual participant dataSharing planned: Yes. data of the patients are available to other researchers upon request
Related trials for Cataract Senile
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Age Related Cataracts
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract
Active, not recruiting
A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent
Glaucoma, Open-Angle, Cataract Senile
RecruitingObservational study
Small RNA tRF-31 Changes in Patients With Age-Related Cataract
Cataract
RecruitingObservational study
The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors
Age-related Cataract
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior chamber illumination in cataract surgery in people with Cataract Senile, run by University of Alexandria 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 9 Jan 2020. 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?
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens (time frame: intraoperative). 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 9 Jan 2020.