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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phacoemulsification and Intraocular lens implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure change | intraocular pressure measurement by Goldman's applanation tonometr | 4 weeks |
| ocular bio-metrics change | anterior chamber angle angle opening distance and anterior chamber depth change | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phacoemulsification as treatment to glaucoma | intraocular pressure decrease after surgery in glaucoma patients | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim A Raafat, MD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Cairo university | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27800269 | Background | 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. | |
| 25765255 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2019 | Apr 2, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2019 | Apr 2, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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All participants are assigned to the same interventions. All will undergo pre- & postoperative assessment, cataract surgery.
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| Ultrasound Biomicrosopy (UBM) | Diagnostic Test | A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault. |
|
| 26650901 | Result | 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. |
| 25644619 | Result | 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. |
| D059708 | Ultrasonic Surgical Procedures |