GlaucomaNCT04334473
IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls
A study testing phacoemulsification and Intraocular lens implantation and Ultrasound Biomicrosopy (UBM) in people with Glaucoma and Cataract, run by Mai Nasser Abd Elmohsen at 1 site in Egypt.
Trial summary
Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- What is being tested?
- phacoemulsification and Intraocular lens implantation and Ultrasound Biomicrosopy (UBM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2019to 1 Apr 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years.
- Glaucomtous and nonglaucomatous participants with visually significant cataracts.
- Best-corrected visual acuity (BCVA) equal to or worse than 6/12.
- patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).
Who cannot join
- Major intraoperative or postoperative complications from cataract surgery
- Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
- Uveitis, severe retinal diseases, or congenital Anomalies.
- History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study
Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.
Read the detailed description
All patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. Anterior Chamber Depth \& lens thickness will be measured by Optical Biometry (lenstar 900) as well as measurement of the angle \& lens vault using the Ultrasound Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- \& postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage, endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of infection: adherence to pre-\& intraoperative infection-control measures, postoperative UBM is to be done at 1 month.
- Being tested
- phacoemulsification and Intraocular lens implantation, Ultrasound Biomicrosopy (UBM)
- Keywords
- Ocular bio-metrics, Anterior chamber depth, UBM
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification and Intraocular lens implantationProcedure or surgery
Standartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference.
Ultrasound Biomicrosopy (UBM)Diagnostic test
A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.
| Study group | Role | What they receive |
|---|---|---|
| cataract patients | Other | Patients having cataract candidates for phacoemulsification with or without glaucoma are prepared to do cataract surgery with preoperative and postoperative assessment of intraocular pressure and ocular bio-metrics using UBM. Receives: Procedure: phacoemulsification and Intraocular lens implantation; Diagnostic Test: Ultrasound Biomicrosopy (UBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure change
intraocular pressure measurement by Goldman's applanation tonometr
Measured: 4 weeks
ocular bio-metrics change
anterior chamber angle angle opening distance and anterior chamber depth change
Measured: 4 weeks
Secondary outcomes (1)
Phacoemulsification as treatment to glaucoma
intraocular pressure decrease after surgery in glaucoma patients
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start20 Sep 2019
- Primary completion15 Mar 2020
- Study completion1 Apr 2020
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 GlaucomaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants are assigned to the same interventions. All will undergo pre- \& postoperative assessment, cataract surgery.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mai Nasser Abd Elmohsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mai Nasser Abd Elmohsen, Kasr El Aini Hospital
- Investigators
- Karim A Raafat, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334473
- Sponsor's protocol ID
- N-45-2019
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elgin U, Sen E, Simsek T, Tekin K, Yilmazbas P. Early Postoperative Effects of Cataract Surgery on Anterior Segment Parameters in Primary Open-Angle Glaucoma and Pseudoexfoliation Glaucoma. Turk J Ophthalmol. 2016 Jun;46(3):95-98. doi: 10.4274/tjo.92604. Epub 2016 Jun 6.
PubMed 27800269Melancia D, Abegao Pinto L, Marques-Neves C. Cataract surgery and intraocular pressure. Ophthalmic Res. 2015;53(3):141-8. doi: 10.1159/000377635. Epub 2015 Mar 7.
PubMed 25765255Hsu CH, Kakigi CL, Lin SC, Wang YH, Porco T, Lin SC. Lens Position Parameters as Predictors of Intraocular Pressure Reduction After Cataract Surgery in Nonglaucomatous Patients With Open Angles. Invest Ophthalmol Vis Sci. 2015 Dec 1;56(13):7807-7813. doi: 10.1167/iovs.15-17926.
PubMed 26650901Man X, Chan NC, Baig N, Kwong YY, Leung DY, Li FC, Tham CC. Anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber drainage angle in primary angle-closure glaucoma (PACG) patients. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):773-8. doi: 10.1007/s00417-015-2936-z. Epub 2015 Feb 3.
PubMed 25644619
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study
- ClinicalTrials.gov ID
- NCT04334473
- Acronym / sponsor ID
- N-45-2019
- Keywords
- Ocular bio-metrics, Anterior chamber depth, UBM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mai Nasser Abd ElmohsenUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 6 Apr 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.
Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.
Detailed description
All patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. Anterior Chamber Depth \& lens thickness will be measured by Optical Biometry (lenstar 900) as well as measurement of the angle \& lens vault using the Ultrasound Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- \& postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage, endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of infection: adherence to pre-\& intraoperative infection-control measures, postoperative UBM is to be done at 1 month.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are assigned to the same interventions. All will undergo pre- \& postoperative assessment, cataract surgery.
| Arm | Type | Receives |
|---|---|---|
| cataract patients | Other | Procedure: phacoemulsification and Intraocular lens implantation, Diagnostic Test: Ultrasound Biomicrosopy (UBM)Patients having cataract candidates for phacoemulsification with or without glaucoma are prepared to do cataract surgery with preoperative and postoperative assessment of intraocular pressure and ocular bio-metrics using UBM. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-70 years.
- Glaucomtous and nonglaucomatous participants with visually significant cataracts.
- Best-corrected visual acuity (BCVA) equal to or worse than 6/12.
- patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).
Key exclusion criteria (4 listed)
- Major intraoperative or postoperative complications from cataract surgery
- Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
- Uveitis, severe retinal diseases, or congenital Anomalies.
- History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery
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 and Intraocular lens implantationStandartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference. | Procedure or surgery | cataract patients |
| Ultrasound Biomicrosopy (UBM)A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault. | Diagnostic test | cataract patients |
Primary outcome
Intraocular pressure change
Time frame: 4 weeks
intraocular pressure measurement by Goldman's applanation tonometr
ocular bio-metrics change
Time frame: 4 weeks
anterior chamber angle angle opening distance and anterior chamber depth change
1 secondary outcome
Phacoemulsification as treatment to glaucoma
Time frame: 4 weeks
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 6 Apr 2020.
- Background: PubMed 27800269Elgin U, Sen E, Simsek T, Tekin K, Yilmazbas P. Early Postoperative Effects of Cataract Surgery on Anterior Segment Parameters in Primary Open-Angle Glaucoma and Pseudoexfoliation Glaucoma. Turk J Ophthalmol. 2016 Jun;46(3):95-98. doi: 10.4274/tjo.92604. Epub 2016 Jun 6.
- Results publication: PubMed 25765255Melancia D, Abegao Pinto L, Marques-Neves C. Cataract surgery and intraocular pressure. Ophthalmic Res. 2015;53(3):141-8. doi: 10.1159/000377635. Epub 2015 Mar 7.
- Results publication: PubMed 26650901Hsu CH, Kakigi CL, Lin SC, Wang YH, Porco T, Lin SC. Lens Position Parameters as Predictors of Intraocular Pressure Reduction After Cataract Surgery in Nonglaucomatous Patients With Open Angles. Invest Ophthalmol Vis Sci. 2015 Dec 1;56(13):7807-7813. doi: 10.1167/iovs.15-17926.
- Results publication: PubMed 25644619Man X, Chan NC, Baig N, Kwong YY, Leung DY, Li FC, Tham CC. Anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber drainage angle in primary angle-closure glaucoma (PACG) patients. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):773-8. doi: 10.1007/s00417-015-2936-z. Epub 2015 Feb 3.
- Individual participant dataSharing planned: No
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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.
Karim A Raafat, MD study director
Cairo 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 phacoemulsification and Intraocular lens implantation and Ultrasound Biomicrosopy (UBM) in people with Glaucoma and Cataract, run by Mai Nasser Abd Elmohsen 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 4 inclusion and 4 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 6 Apr 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.
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?
Intraocular pressure change (time frame: 4 weeks). 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 NCT04334473, 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 6 Apr 2020.