CataractNCT06745596
Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber
A study testing cataract surgery 1 and cataract surgery 2 in people with Cataract, run by Zagazig University at 1 site in Egypt.
Trial summary
Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery 1 and cataract surgery 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2022to 24 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anterior chamber depth of less than 2.8 mm associated with cataract
Who cannot join
- Mature cataract
- History of previous ocular surgery
- Posterior segment pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber with and Without Limited Anterior Pars Plana Vitrectomy
Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps
Read the detailed description
Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps. This study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber.
Methods: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.
- Conditions
- Cataract
- Being tested
- cataract surgery 1, cataract surgery 2
- Keywords
- Limited anterior pars plana vitrectomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgery 1Procedure or surgery
Cataract with limited anterior pars plana vitrectomy
cataract surgery 2Procedure or surgery
cataract without limited anterior pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Cataract with limited anterior pars plana vitrectomy | Active comparator | group I included twelve patients who underwent phacoemulsification combined with limited anterior pars plana vitrectomy Receives: Procedure: cataract surgery 1 |
| Cataract without limited anterior pars plana vitrectomy | Active comparator | group II included twelve patients that underwent phacoemulsification only Receives: Procedure: cataract surgery 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness in micrometers.
Central corneal thickness in both groups measured by anterior segment OCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start22 Mar 2022
- Primary completion2 Feb 2024
- Study completion24 Jun 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mahmoud Mohammad Gamal Mohammad Gamal, MBBCh, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745596
- Sponsor's protocol ID
- #467/24-June-2024.
- Other IDs
- Zagazig university
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber with and Without Limited Anterior Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT06745596
- Acronym / sponsor ID
- #467/24-June-2024.
- Conditions
- Cataract
- Keywords
- Limited anterior pars plana vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 20 Dec 2024 (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.
Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps
Detailed description
Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps. This study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber.
Methods: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only
| Arm | Type | Receives |
|---|---|---|
| Cataract with limited anterior pars plana vitrectomy | Active comparator | Procedure: cataract surgery 1group I included twelve patients who underwent phacoemulsification combined with limited anterior pars plana vitrectomy |
| Cataract without limited anterior pars plana vitrectomy | Active comparator | Procedure: cataract surgery 2group II included twelve patients that underwent phacoemulsification only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anterior chamber depth of less than 2.8 mm associated with cataract
Key exclusion criteria (3 listed)
- Mature cataract
- History of previous ocular surgery
- Posterior segment pathology
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 |
|---|---|---|
| cataract surgery 1Cataract with limited anterior pars plana vitrectomy | Procedure or surgery | Cataract with limited anterior pars plana vitrectomy |
| cataract surgery 2cataract without limited anterior pars plana vitrectomy | Procedure or surgery | Cataract without limited anterior pars plana vitrectomy |
Primary outcome
Central corneal thickness in micrometers.
Time frame: 6 months
Central corneal thickness in both groups measured by anterior segment OCT
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 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Mahmoud Mohammad Gamal Mohammad Gamal, MBBCh study director
Zagazig 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 cataract surgery 1 and cataract surgery 2 in people with Cataract, run by Zagazig 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 3 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 Dec 2024. 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?
Central corneal thickness in micrometers. (time frame: 6 months). 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 Dec 2024.