Corneal Endothelial Changes After PhacoemulsificationNCT05426590
Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level
A study testing Specular biomicroscopy in people with Corneal Endothelial Changes After Phacoemulsification, run by Marwa Ahmed at 1 site in Egypt.
Trial summary
Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Corneal Endothelial Changes After Phacoemulsification
- What is being tested?
- Specular biomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2022to 17 Nov 2022
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetics and non-diabetic patients undergo cataract surgery
- Age between 50-60 years old
- Corrected distance visual acuity<0.4
- Gender: both genders.
Who cannot join
- Chronic Ocular diseases (glaucoma,uveitis, amblyopia, strabismus,keratoconus, corneal opacity).
- corneal dystrophy History of previous keratitis or viral corneal infection. Corneal dystrophy Ocular trauma. Previous ocular surgery. Complicated cataract surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mohamed A Hosny, 01000007676, Mohamedhosny@kasralainy.edu.eg
About this study
Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level
Read the detailed description
86 patients will be divided into two equal groups of diabetic and non-diabetic patients will undergo phacoemulsification of cataract will be evaluated thier endocelium before surgery and 3 weeks after surgery to detect the effect of level of glcosylated hemoglobin on the endothelial changes after uneventful phacoemulsification
- Being tested
- Specular biomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specular biomicroscopyDevice
Specular microscopy will be done before and 3 weeks after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patient | Active comparator | Patient with diabetes will undergo cataract surgery Receives: Device: Specular biomicroscopy |
| Non diabetic patients | Active comparator | Healthy non diabetic patients will undergo cataract surgery Receives: Device: Specular biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification
Detect effect of glycosylated hemoglobin level after uneventful phacoemulsification in diabetic and non-diabetic patients
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start20 May 2022
- Primary completion17 Nov 2022 (estimated)
- Study completion17 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Changes After PhacoemulsificationStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Ahmed, Cairo University
- Investigators
- Mohamed A Hosny, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426590
- Sponsor's protocol ID
- KasrAlAiny
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level
- ClinicalTrials.gov ID
- NCT05426590
- Acronym / sponsor ID
- KasrAlAiny
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Marwa AhmedUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 17 Nov 2022 (estimated)
- Study completion
- 17 Nov 2022 (estimated)
- First posted
- 22 Jun 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.
Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level
Detailed description
86 patients will be divided into two equal groups of diabetic and non-diabetic patients will undergo phacoemulsification of cataract will be evaluated thier endocelium before surgery and 3 weeks after surgery to detect the effect of level of glcosylated hemoglobin on the endothelial changes after uneventful phacoemulsification
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patient | Active comparator | Device: Specular biomicroscopyPatient with diabetes will undergo cataract surgery |
| Non diabetic patients | Active comparator | Device: Specular biomicroscopyHealthy non diabetic patients will undergo cataract surgery |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetics and non-diabetic patients undergo cataract surgery
- Age between 50-60 years old
- Corrected distance visual acuity<0.4
- Gender: both genders.
Key exclusion criteria (2 listed)
- Chronic Ocular diseases (glaucoma,uveitis, amblyopia, strabismus,keratoconus, corneal opacity).
- corneal dystrophy History of previous keratitis or viral corneal infection. Corneal dystrophy Ocular trauma. Previous ocular surgery. Complicated cataract surgery
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 |
|---|---|---|
| Specular biomicroscopySpecular microscopy will be done before and 3 weeks after cataract surgery | Device | Diabetic patient, Non diabetic patients |
Primary outcome
Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification
Time frame: 6 monthes
Detect effect of glycosylated hemoglobin level after uneventful phacoemulsification in diabetic and non-diabetic patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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.
Mohamed A Hosny, MD principal investigator
Cairo 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 Specular biomicroscopy in people with Corneal Endothelial Changes After Phacoemulsification, run by Marwa Ahmed 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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa A Abdelaal (01129875785, Magicoromi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification (time frame: 6 monthes). 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 22 Jun 2022.