Corneal EdemaPhase 3NCT05271058
Effect of Intracameral Steroids During Phacoemulsification on the Cornea
A Phase 3 study testing Dexamethasone group and Triamcinolone (TA) group in people with Corneal Edema, run by Cairo University at 1 site in Egypt.
Trial summary
Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Corneal Edema
- What is being tested?
- Dexamethasone group and Triamcinolone (TA) group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2019to 15 Aug 2020
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract grades 2 to 5 nuclear cataract (LOCS III scale)
- uneventful phacoemulsification operation
Who cannot join
- extremely hard cataract grade 6 nuclear cataract (LOCS III scale)
- soft cataract
- subluxated lenses or zonular dehiscence
- associated ocular pathology such as glaucoma
- any signs of uveitis
- trauma
Show all 12Show fewer
- retinal detachment
- vitrectomized or silicone filled eyes
- corneal disease such as Fuch's dystrophy, corneal opacity
- previous refractive corneal surgery
- Cases that developed ruptured posterior capsule and vitreous loss
- those lost to follow up were excluded and randomly replaced by the next chronological patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.
Read the detailed description
Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.
Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
On the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.
One month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.
mean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively.
- Conditions
- Corneal Edema
- Being tested
- Control group, Dexamethasone group, Triamcinolone (TA) group
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Also called No intraoperative steroids
23 eyes that didn't receive any intraoperative steroids
Dexamethasone groupDrug
Also called Intracameral Dexamethasone
23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification.
Triamcinolone (TA) groupDrug
Also called Intracameral triamcinolone (TA)
23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification.
| Study group | Role | What they receive |
|---|---|---|
| Control group 1 | Sham comparator | 23 eyes that did not receive any intraoperative steroids Receives: Other: Control group |
| Dexamethasone group 2 | Active comparator | 23 eyes that received intracameral dexamethasone Receives: Drug: Dexamethasone group |
| Triamcinolone (TA) group 3 | Active comparator | 23 eyes that received intracameral triamcinolone (TA) Receives: Drug: Triamcinolone (TA) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal edema
Clinical grade of corneal edema on the first postoperative day
Measured: First day postoperative
Central corneal thickness (CCT)
Central corneal thickness in microns after phacoemulsification that was compared to preoperative values
Measured: Three months
Endothelial cell loss
Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values
Measured: Three months
Secondary outcomes (1)
IOP
Intraocular pressure in mmHg rise after after phacoemulsification
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start16 Jun 2019
- Primary completion16 Jun 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count. Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, khaled gamal abueleinen, Cairo University
- Investigators
- Khaled G Abueleinen, MD, PhD, Principal investigator, Ophthalmology department, Faculty of Medicine Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271058
- Sponsor's protocol ID
- FMBSUREC/30042019/Mohamed
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 8 Mar 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
- ClinicalTrials.gov ID
- NCT05271058
- Acronym / sponsor ID
- FMBSUREC/30042019/Mohamed
- Conditions
- Corneal Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 8 Mar 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.
Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.
Detailed description
Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.
Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
On the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.
One month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.
mean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count. Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
| Arm | Type | Receives |
|---|---|---|
| Control group 1 | Sham comparator | Other: Control group23 eyes that did not receive any intraoperative steroids |
| Dexamethasone group 2 | Active comparator | Drug: Dexamethasone group23 eyes that received intracameral dexamethasone |
| Triamcinolone (TA) group 3 | Active comparator | Drug: Triamcinolone (TA) group23 eyes that received intracameral triamcinolone (TA) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract grades 2 to 5 nuclear cataract (LOCS III scale)
- uneventful phacoemulsification operation
Key exclusion criteria (12 listed)
- extremely hard cataract grade 6 nuclear cataract (LOCS III scale)
- soft cataract
- subluxated lenses or zonular dehiscence
- associated ocular pathology such as glaucoma
- any signs of uveitis
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 |
|---|---|---|
| Control groupAlso: No intraoperative steroids23 eyes that didn't receive any intraoperative steroids | Other | Control group 1 |
| Dexamethasone groupAlso: Intracameral Dexamethasone23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification. | Drug | Dexamethasone group 2 |
| Triamcinolone (TA) groupAlso: Intracameral triamcinolone (TA)23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification. | Drug | Triamcinolone (TA) group 3 |
Primary outcome
Corneal edema
Time frame: First day postoperative
Clinical grade of corneal edema on the first postoperative day
Central corneal thickness (CCT)
Time frame: Three months
Central corneal thickness in microns after phacoemulsification that was compared to preoperative values
Endothelial cell loss
Time frame: Three months
Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values
1 secondary outcome
IOP
Time frame: Three 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 8 Mar 2022.
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The Belgian Endothelial Surgical Transplant of the Cornea
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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.
Khaled G Abueleinen, MD, PhD principal investigator
Ophthalmology department, Faculty of Medicine Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone group and Triamcinolone (TA) group in people with Corneal Edema, run by Cairo 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 2 inclusion and 12 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 8 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Corneal edema (time frame: First day postoperative). The study lists 3 primary outcomes in all. 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 8 Mar 2022.