Back to resultsIOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls
Primary Purpose
Glaucoma, Cataract
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
phacoemulsification and Intraocular lens implantation
Ultrasound Biomicrosopy (UBM)
Sponsored by
About this trial
This is an interventional basic science trial for Glaucoma focused on measuring Ocular bio-metrics, Anterior chamber depth, UBM
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Faculty of medicine, Cairo university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cataract patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Intraocular pressure change
intraocular pressure measurement by Goldman's applanation tonometr
ocular bio-metrics change
anterior chamber angle angle opening distance and anterior chamber depth change
Secondary Outcome Measures
Phacoemulsification as treatment to glaucoma
intraocular pressure decrease after surgery in glaucoma patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04334473
Brief Title
IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls
Official Title
Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mai Nasser Abd Elmohsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract
Keywords
Ocular bio-metrics, Anterior chamber depth, UBM
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants are assigned to the same interventions. All will undergo pre- & postoperative assessment, cataract surgery.
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cataract patients
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and Intraocular lens implantation
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound Biomicrosopy (UBM)
Intervention Description
A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.
Primary Outcome Measure Information:
Title
Intraocular pressure change
Description
intraocular pressure measurement by Goldman's applanation tonometr
Time Frame
4 weeks
Title
ocular bio-metrics change
Description
anterior chamber angle angle opening distance and anterior chamber depth change
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Phacoemulsification as treatment to glaucoma
Description
intraocular pressure decrease after surgery in glaucoma patients
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim A Raafat, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine, Cairo university
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27800269
Citation
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.
Results Reference
background
PubMed Identifier
25765255
Citation
Melancia 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 Reference
result
PubMed Identifier
26650901
Citation
Hsu 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 Reference
result
PubMed Identifier
25644619
Citation
Man 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.
Results Reference
result
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IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls
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