CataractPhase 4NCT03638726
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
A Phase 4 study testing Atropine sulfate and epinephrine and Topical cyclopentolate and phenylephrine in people with Cataract and Mydriasis, run by Dar El Oyoun Hospital at 1 site in Egypt.
Trial summary
Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cataract, Mydriasis, Adverse Drug Event
- What is being tested?
- Atropine sulfate and epinephrine and Topical cyclopentolate and phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2018to Jun 2019
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases of bilateral visually significant cataract
Who cannot join
- Poor pupil dilation(less than 6 mm diameter).
- History of previous eye surgery or trauma
- History of use of eye drops affecting pupil size such as pilocarpine.
- Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine.
- Pediatric age group (less than 18 years old).
- Pupil abnormalities, such as anisocoria or neurological disorders.
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- Associated glaucoma, uveitis, corneal, retinal or optic nerve disease.
- Cases scheduled for phacoemulsification under general anaesthesia (to exclude possible ocular and systemic effects or interactions of anaesthetic agents).
- Patients with bleeding tendency or on anti-coagulant therapy (because peribulbar and subconjunctival injections are used).
Trial locations and contacts
1 site in 1 country.
Ali contact
Egypt1 site, 1 recruiting
- Recruiting
Dar El Oyoun Hospital
Cairo, Giza Governorate, 1261
Khaled Samir, MD
About this study
Official title: Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.
Read the detailed description
The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.
- Conditions
- Cataract, Mydriasis, Adverse Drug Event
- Being tested
- Atropine sulfate and epinephrine, Topical cyclopentolate and phenylephrine
- Keywords
- intraoperative mydriasis, subconjunctival atropine, intracameral epinephrine, cataract surgery
- Medical subject headings
- Cataract, Mydriasis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine sulfate and epinephrineDrug
Also called Atropine (Misr.co), Epinephrine (Misr.co)
Experimental arm:Combined use of subconjunctival atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral epinephrine 1:100000 ( sympathetic agonist). Control arm :topical mydriatics are used for pupil dilation.
Topical cyclopentolate and phenylephrineDrug
Also called Cyclophrine eye drops
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
| Study group | Role | What they receive |
|---|---|---|
| Atropine sulfate and Epinephrine | Experimental | Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist). Receives: Drug: Atropine sulfate and epinephrine |
| Topical cyclopentolate and phenylephrine | Other | Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine. Receives: Drug: Topical cyclopentolate and phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pupil diameter
Intraoperative pupil diameter measurements of involved eye in mm
Measured: 1 day
Secondary outcomes (6)
Postoperative complications
Complications such as subconjunctival hemorrhage or corneal edema
[Time Frame: starting from the first postoperative day till one month]
Measured: Starting from first postoperative day till one month.
Postoperative corneal thickness
Measured by specular microscopy in ( mm )
Measured: 1 month after surgery
Postoperative corneal endothelial density
Measured by specular microscopy in ( cell number/mm2)
Measured: 1 month after surgery
Postoperative pupil diameter
Postoperative diameter of involved eye in mm
Measured: one day, one week and one month after surgery
Postoperative visual acuity
Postoperative best corrected distance visual acuity in logmar units.
Measured: One day, one week and one month after surgery
Postoperative intraocular pressure (IOP)
Postoperative IOP measured in mmHg
Measured: One day, one week and one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start28 Sep 2018
- Primary completionMar 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar El Oyoun Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ashraf Nossair, MD, Dar El Oyoun Hospital
- Investigators
- Nossair, Principal investigator, Dar El Oyoun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638726
- Sponsor's protocol ID
- IRB 00001211
- Status last verified
- Oct 2018
- First submitted
- 5 Feb 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Identity and names of participant will be hidden. Data related to outcome measures can be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
- ClinicalTrials.gov ID
- NCT03638726
- Acronym / sponsor ID
- IRB 00001211
- Conditions
- Cataract, Mydriasis, Adverse Drug Event
- Keywords
- intraoperative mydriasis, subconjunctival atropine, intracameral epinephrine, cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dar El Oyoun HospitalUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 Aug 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.
Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.
Detailed description
The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Atropine sulfate and Epinephrine | Experimental | Drug: Atropine sulfate and epinephrinePerioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist). |
| Topical cyclopentolate and phenylephrine | Other | Drug: Topical cyclopentolate and phenylephrinePreoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cases of bilateral visually significant cataract
Key exclusion criteria (9 listed)
- Poor pupil dilation(less than 6 mm diameter).
- History of previous eye surgery or trauma
- History of use of eye drops affecting pupil size such as pilocarpine.
- Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine.
- Pediatric age group (less than 18 years old).
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 |
|---|---|---|
| Atropine sulfate and epinephrineAlso: Atropine (Misr.co), Epinephrine (Misr.co)Experimental arm:Combined use of subconjunctival atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral epinephrine 1:100000 ( sympathetic agonist). Control arm :topical mydriatics are used for pupil dilation. | Drug | Atropine sulfate and Epinephrine |
| Topical cyclopentolate and phenylephrineAlso: Cyclophrine eye dropsControl arm: Preoperative cyclopentolate and phenylephrine eye drops are used. | Drug | Topical cyclopentolate and phenylephrine |
Primary outcome
Intraoperative pupil diameter
Time frame: 1 day
Intraoperative pupil diameter measurements of involved eye in mm
6 secondary outcomes
Postoperative complications
Time frame: Starting from first postoperative day till one month.
Postoperative corneal thickness
Time frame: 1 month after surgery
Postoperative corneal endothelial density
Time frame: 1 month after surgery
Postoperative pupil diameter
Time frame: one day, one week and one month after surgery
Postoperative visual acuity
Time frame: One day, one week and one month after surgery
Postoperative intraocular pressure (IOP)
Time frame: One day, one week and one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided. Identity and names of participant will be hidden. Data related to outcome measures can be shared
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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.
Ali contact
Nossair principal investigator
Dar El Oyoun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine sulfate and epinephrine and Topical cyclopentolate and phenylephrine in people with Cataract and Mydriasis, run by Dar El Oyoun Hospital 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 9 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 9 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ewais (+01223638543, waelewais74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative pupil diameter (time frame: 1 day). 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 Oct 2018.