Cataract DiabeticNCT03755752
Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
A study testing Phacoemulsification with and without Trypan Blue capsule staining in people with Cataract Diabetic, run by Assiut University at 1 site in Egypt.
Trial summary
This study examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cataract Diabetic
- What is being tested?
- Phacoemulsification with and without Trypan Blue capsule staining
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 31 Aug 2018
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral cataract and diabetic retinopathy
Who cannot join
- History of ocular surgery Active
- ocular inflammation Corneal opacities
- Pseudoexfoliation syndrome
- Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
- Iris neovascularization (rubeosis)
- Uncontrolled glaucoma
Show all 11Show fewer
- Congenital or traumatic cataracts
- History or present chronic use of topical or systemic steroids
- Poor papillary dilatation (<6 mm)
- Specular microscopy cell density < 2000 cell/mm2
- Patients who experienced complications fromphacoemulsification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy
This study examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. One eye in each patient with diabetic retinopathy will undergo phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes will undergo intraocular lens implantation. Preoperative and four-week postoperative quantitative and qualitative morphometric endothelial cell analyses of the cornea will be performed using noncontact specular microscopy.
- Conditions
- Cataract Diabetic
- Being tested
- Phacoemulsification with and without Trypan Blue capsule staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with and without Trypan Blue capsule stainingProcedure or surgery
Phacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue.
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification with Trypan Blue | Experimental | Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy Receives: Procedure: Phacoemulsification with and without Trypan Blue capsule staining |
| Phacoemulsification without Trypan Blue | Experimental | Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with Receives: Procedure: Phacoemulsification with and without Trypan Blue capsule staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell density
Measured: 4 weeks
Secondary outcomes (3)
Endothelial cell coefficient of variation
Measured: 4 weeks
Percent of hexagonal cells
Measured: 4 weeks
Mean corneal thickness
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Jan 2018
- Primary completion25 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract DiabeticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755752
- Sponsor's protocol ID
- 17300250
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelmotaal H, Abdelazeem K, Hussein MS, Omar AF, Ibrahim W. Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients with Diabetic Retinopathy. J Ophthalmol. 2019 Mar 27;2019:4018739. doi: 10.1155/2019/4018739. eCollection 2019.
PubMed 31032113
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03755752
- Acronym / sponsor ID
- 17300250
- Conditions
- Cataract Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 28 Nov 2018 (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 examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. One eye in each patient with diabetic retinopathy will undergo phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes will undergo intraocular lens implantation. Preoperative and four-week postoperative quantitative and qualitative morphometric endothelial cell analyses of the cornea will be performed using noncontact specular microscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification with Trypan Blue | Experimental | Procedure: Phacoemulsification with and without Trypan Blue capsule stainingPhacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy |
| Phacoemulsification without Trypan Blue | Experimental | Procedure: Phacoemulsification with and without Trypan Blue capsule stainingPhacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bilateral cataract and diabetic retinopathy
Key exclusion criteria (11 listed)
- History of ocular surgery Active
- ocular inflammation Corneal opacities
- Pseudoexfoliation syndrome
- Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
- Iris neovascularization (rubeosis)
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 with and without Trypan Blue capsule stainingPhacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue. | Procedure or surgery | Phacoemulsification with Trypan Blue, Phacoemulsification without Trypan Blue |
Primary outcome
Endothelial cell density
Time frame: 4 weeks
3 secondary outcomes
Endothelial cell coefficient of variation
Time frame: 4 weeks
Percent of hexagonal cells
Time frame: 4 weeks
Mean corneal thickness
Time frame: 4 weeks
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 28 Nov 2018.
- Derived from this study: PubMed 31032113Abdelmotaal H, Abdelazeem K, Hussein MS, Omar AF, Ibrahim W. Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients with Diabetic Retinopathy. J Ophthalmol. 2019 Mar 27;2019:4018739. doi: 10.1155/2019/4018739. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification with and without Trypan Blue capsule staining in people with Cataract Diabetic, run by Assiut 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 11 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 28 Nov 2018. 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?
Endothelial cell density (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755752, which also lists 1 linked publication.
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 28 Nov 2018.