OphthalmopathyPDT vs PTNCT04683055
Phaco-Trabeculotomy Vs Phaco-Trabeculectomy
A study testing Phacoemulsification combined with trabeculectomy and Phacoemulsificaiton combined with ab-externo trabeculotomy in people with Ophthalmopathy and Glaucoma, run by Assiut University at 1 site in Egypt.
Trial summary
A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ophthalmopathy, Glaucoma, Glaucoma, Angle-Closure
- What is being tested?
- Phacoemulsification combined with trabeculectomy and Phacoemulsificaiton combined with ab-externo trabeculotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Oct 2020to 1 May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18
Who cannot join
- Patient unable for follow up
- Patients with corneal or retinal disease that affects visual outcome of surgery
- Patients with previous glaucoma procedure in the eye of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma
A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.
Read the detailed description
Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.
- Conditions
- Ophthalmopathy, Glaucoma, Glaucoma, Angle-Closure
- Being tested
- Phacoemulsification combined with trabeculectomy, Phacoemulsificaiton combined with ab-externo trabeculotomy
- Medical subject headings
- Eye Diseases, Glaucoma, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification combined with trabeculectomyProcedure or surgery
Patients with chronic angle closure glaucoma assigned to this group will have fornex based trabeculectomy at superior limbus and then phacoemulsification via temporal incision
Phacoemulsificaiton combined with ab-externo trabeculotomyProcedure or surgery
Patients with chronic angle closure glaucoma assigned to this group will have Deep Sclerectomy with ab externo trabeculotomy at superior limbus and then phacoemulsification via temporal incision
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification combined with trabeculectomy | Active comparator | Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C Receives: Procedure: Phacoemulsification combined with trabeculectomy |
| Phacoemulsificaiton combined with ab-externo trabeculotomy | Active comparator | Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy Receives: Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Success
Reduction of IOP more than 30% on no glaucoma drops
Measured: 1,3,6 months
Visual outcome
Uncorrected visual acuity by Snellen's chart
Measured: 1,3,6 month
Secondary outcomes (1)
Adverse events
all intraoperative and postoperative adverse events witt be recorded
Measured: 1 week, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start28 Oct 2020
- Primary completion31 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OphthalmopathyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud F. Rateb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683055
- Sponsor's protocol ID
- IRB17300506
- Acronym
- PDT vs PT
- Status last verified
- Oct 2021
- First submitted
- 20 Dec 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data in the study , after completion after de-identification
Publications
Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
PubMed 11713061Rebolleda G, Munoz-Negrete FJ. Phacoemulsification in eyes with functioning filtering blebs: a prospective study. Ophthalmology. 2002 Dec;109(12):2248-55. doi: 10.1016/s0161-6420(02)01246-0.
PubMed 12466166Hansapinyo L, Choy BNK, Lai JSM, Tham CC. Phacoemulsification Versus Phacotrabeculectomy in Primary Angle-closure Glaucoma With Cataract: Long-Term Clinical Outcomes. J Glaucoma. 2020 Jan;29(1):15-23. doi: 10.1097/IJG.0000000000001397.
PubMed 31702714Toteberg-Harms M, Wachtl J, Schweier C, Funk J, Kniestedt C. Long-term efficacy of combined phacoemulsification plus trabeculectomy versus phacoemulsification plus excimer laser trabeculotomy. Klin Monbl Augenheilkd. 2017 Apr;234(4):457-463. doi: 10.1055/s-0043-100291. Epub 2017 Mar 6.
PubMed 28264221
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma
- ClinicalTrials.gov ID
- NCT04683055
- Acronym / sponsor ID
- PDT vs PT / IRB17300506
- Conditions
- Ophthalmopathy, Glaucoma, Glaucoma, Angle-Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 24 Dec 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.
A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.
Detailed description
Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification combined with trabeculectomy | Active comparator | Procedure: Phacoemulsification combined with trabeculectomyPatients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C |
| Phacoemulsificaiton combined with ab-externo trabeculotomy | Active comparator | Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomyPatients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18
Key exclusion criteria (3 listed)
- Patient unable for follow up
- Patients with corneal or retinal disease that affects visual outcome of surgery
- Patients with previous glaucoma procedure in the eye of study
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 combined with trabeculectomyPatients with chronic angle closure glaucoma assigned to this group will have fornex based trabeculectomy at superior limbus and then phacoemulsification via temporal incision | Procedure or surgery | Phacoemulsification combined with trabeculectomy |
| Phacoemulsificaiton combined with ab-externo trabeculotomyPatients with chronic angle closure glaucoma assigned to this group will have Deep Sclerectomy with ab externo trabeculotomy at superior limbus and then phacoemulsification via temporal incision | Procedure or surgery | Phacoemulsificaiton combined with ab-externo trabeculotomy |
Primary outcome
Absolute Success
Time frame: 1,3,6 months
Reduction of IOP more than 30% on no glaucoma drops
Visual outcome
Time frame: 1,3,6 month
Uncorrected visual acuity by Snellen's chart
1 secondary outcome
Adverse events
Time frame: 1 week, 1 month, 3 months, 6 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 29 Oct 2021.
- Background: PubMed 11713061Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
- Background: PubMed 12466166Rebolleda G, Munoz-Negrete FJ. Phacoemulsification in eyes with functioning filtering blebs: a prospective study. Ophthalmology. 2002 Dec;109(12):2248-55. doi: 10.1016/s0161-6420(02)01246-0.
- Background: PubMed 31702714Hansapinyo L, Choy BNK, Lai JSM, Tham CC. Phacoemulsification Versus Phacotrabeculectomy in Primary Angle-closure Glaucoma With Cataract: Long-Term Clinical Outcomes. J Glaucoma. 2020 Jan;29(1):15-23. doi: 10.1097/IJG.0000000000001397.
- Background: PubMed 28264221Toteberg-Harms M, Wachtl J, Schweier C, Funk J, Kniestedt C. Long-term efficacy of combined phacoemulsification plus trabeculectomy versus phacoemulsification plus excimer laser trabeculotomy. Klin Monbl Augenheilkd. 2017 Apr;234(4):457-463. doi: 10.1055/s-0043-100291. Epub 2017 Mar 6.
- Individual participant dataSharing planned: Yes. All of the individual participant data in the study , after completion after de-identification
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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 combined with trabeculectomy and Phacoemulsificaiton combined with ab-externo trabeculotomy in people with Ophthalmopathy and Glaucoma, 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 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 29 Oct 2021. 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?
Absolute Success (time frame: 1,3,6 months). The study lists 2 primary outcomes in all. 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 NCT04683055, which also lists 4 linked publications.
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 29 Oct 2021.