Corneal Endothelial Cell LossPhase 3NCT04396301
Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco
A Phase 3 study testing Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). in people with Corneal Endothelial Cell Loss and Mydriasis, run by Cairo University at 1 site in Egypt.
Trial summary
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Corneal Endothelial Cell Loss, Mydriasis, Cataract
- What is being tested?
- Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Sep 2019
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medium density cataract (nuclear II to III)
Who cannot join
- soft or hard density cataract (nuclear I or IV)
- history of ocular trauma or previous intraocular surgery
- iatrogenic, congenital or traumatic cataract
- associated eye disease e.g. pseudoexofoliation syndrome
- associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
- associated systemic disease that can affect endothelium,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.
Read the detailed description
in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.
- Conditions
- Corneal Endothelial Cell Loss, Mydriasis, Cataract
- Being tested
- Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
- Keywords
- corneal endothelial cell count, Fydrane, mixed mydriatic and anaesthetic combination, intracameral mydriatic, mydriasis, phacoemulsification
- Medical subject headings
- Corneal Endothelial Cell Loss, Mydriasis, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).Drug
Also called Mydrane
Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
| Study group | Role | What they receive |
|---|---|---|
| Fydrane group | Active comparator | Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used. Receives: Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). |
| Reference group: | No intervention | not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of intracameral Fydrane on endothelial cell count
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative
Measured: 3 weeks postoperative
Secondary outcomes (1)
effect of Fydrane on pupil diameter during phacoemulsification
Fydrane Efficacy in achieving and maintaining mydiasis, is evaluated by measuring pupil diameter using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Measured: pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell LossStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshewy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396301
- Sponsor's protocol ID
- CU-oph-02-2019
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification
- ClinicalTrials.gov ID
- NCT04396301
- Acronym / sponsor ID
- CU-oph-02-2019
- Conditions
- Corneal Endothelial Cell Loss, Mydriasis, Cataract
- Keywords
- corneal endothelial cell count, Fydrane, mixed mydriatic and anaesthetic combination, intracameral mydriatic, mydriasis, phacoemulsification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 May 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.
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.
Detailed description
in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fydrane group | Active comparator | Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used. |
| Reference group: | No intervention | –not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medium density cataract (nuclear II to III)
Key exclusion criteria (6 listed)
- soft or hard density cataract (nuclear I or IV)
- history of ocular trauma or previous intraocular surgery
- iatrogenic, congenital or traumatic cataract
- associated eye disease e.g. pseudoexofoliation syndrome
- associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy
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 |
|---|---|---|
| Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).Also: MydraneFydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml. | Drug | Fydrane group |
Primary outcome
safety of intracameral Fydrane on endothelial cell count
Time frame: 3 weeks postoperative
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative
1 secondary outcome
effect of Fydrane on pupil diameter during phacoemulsification
Time frame: pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
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 May 2020.
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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 Phase 3 study testing Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). in people with Corneal Endothelial Cell Loss and Mydriasis, 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 1 inclusion and 6 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 May 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.
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?
safety of intracameral Fydrane on endothelial cell count (time frame: 3 weeks postoperative). 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 May 2020.