Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma

NCT03494465 | Completed DMC

• 1 other identifier: FACOPEX
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

There are several publications that have demonstrated the protective role of cataract surgery against the development of long-term glaucoma, especially in cases of pseudoexfoliation glaucoma (PXFG). Cataract surgery in patients with pseudoexfoliation (PXF) is a procedure with higher rates of complications due to its smaller pupillary diameter and its greater zonular weakness, so lens extraction performed earlier could possibly reduce intra and postoperative complications. Given the severity and high prevalence of PXFG in our environment, investigators proposed a randomized clinical trial to evaluate the efficacy of cataract surgery in reducing the intraocular pressure (IOP) at 12 months and thereby change the course of the disease. The control group will have glaucoma treatment according to standard practice.

Conditions

Pseudoexfoliation Glaucoma; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• INTRAOCULAR PRESSURE

  The primary outcome will be the intraocular pressure (IOP) reduction 12 months after randomisation

  12 months

Secondary Outcomes (9)

• VISUAL FIELD INDEX

  12 months

• RETINAL NERVE FIBER LAYER

  12 months

• INCIDENCE OF GLAUCOMA SURGERY

  12 months

• BEST CORRECTED VISUAL ACUITY

  12 months

• QUALITY OF LIFE. VFI Q25 CUESTIONAIRE

  12 months

Study Arms (2)

MEDICAL TREATMENT GROUP

ACTIVE COMPARATOR

Medical treatment will be used in a staggered manner and may also associate laser trabeculoplasty. If necessary, then surgical treatment would be indicated: trabeculectomy. or another filtering surgery. Inadequate IOP control will be determined by the local ophthalmologist, and additional treatment will be indicated to achieve an target IOP.

Drug: MEDICAL GLAUCOMA TREATMENT

INTERVENTION GROUP

EXPERIMENTAL

In lens extraction arm, patients will undergo lens phacoemulsification with intraocular lens implant (IOL) within 60 days after randomization. If additional treatment is required, the same stepped sequence of therapy described for "medical treatment group" will be used and will be considered a therapeutic failure.

Procedure: PHACOEMULSIFICATION

Interventions

PHACOEMULSIFICATION PROCEDURE

Standard phacoemulsification with intraocular lens implant will be perform within 60 days after allocation. If IOP target is not achieve, patients will be treated as in "medical treatment group"

INTERVENTION GROUP

MEDICAL GLAUCOMA TREATMENT DRUG

The escalation of topical hypotensive medications will be carried out with the following sequence: 1. single topical medication; 2. double topical therapy; 3. triple topical therapy. Beginning, with the exception of individual contraindications, with prostaglandin analogs, followed by topical beta-blockers, carbonic anhydrase inhibitors and finally alpha-agonists.Target IOP will be used in both groups to inform the need of escalation of therapy; in patients with ocular hypertension the target IOP will be 21 mmHg. In patients with mild glaucoma target IOP will be 18 mmHg, and in patients with moderate glaucoma the target IOP will be 15 mmHg.

MEDICAL TREATMENT GROUP

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of cataract with visual symptoms that justify the intervention, such as photophobia, difficulty in activities of daily living or driving.
• Mild or moderate PXF glaucoma or ocular hypertension (OHT) over 25mmHg + PXF syndrome.
• Glaucoma is defined as: reproducible defects (two or more contiguous points with a loss of P \<0.01, three or more contiguous points with a loss of P \<0.05 or greater) in the visual field (VF) or , ophthalmoscopically detectable damage to the optic nerve (cup disc ratio\> or = 0.7 and / or focal thinning of the optic nerve rim and / or asymmetry of cup disc ratio \> or = 0.2 between both eyes).
• PXF is defined clinically by the presence of pseudoexfoliative material in the anterior capsule of the lens.
• Mild glaucoma is defined as MD\< 6dB. Moderate glaucoma is defined as MD \< 12dB.
• Naive patients or without topical hypotensive treatment in the last 3 months.
• Age: patients \> 60 years.
• Best corrected visual acuity (BCVA) between range \> 0.4 and \<0.7
• Signature of the specific informed consent of the study.

You may not qualify if:

• Advanced glaucoma. It is defined as an average deviation \> -15dB and / or threat of fixation (paracentral point with sensitivity of 0 dB), and / or cup disc ratio \> 0.9
• Corneal edema, corneal opacity or any other known corneal factor that may increase the risk of complications during surgery
• Previous cataract surgery in the eye included in the study
• Axial length \<20 mm
• Estimated IOL power\> 30 diopters
• Visual acuity \<0.4 or\> 0.7
• Signs of zonular weakness: phacodonesis, iridodonesis, lens subluxation, asymmetry of anterior chamber depth
• Pupillary dilation \<5 mm
• Advanced cataract

Sponsors & Collaborators

• Xerencia de Xestión Integrada de Ferrol: lead

Study Sites (1)

Sara Pose-Bazarra

Ferrol, A Coruna, 15405, Spain

Location

Related Publications (23)

• Ritch R. Exfoliation syndrome. Curr Opin Ophthalmol. 2001 Apr;12(2):124-30. doi: 10.1097/00055735-200104000-00008.

  PMID: 11224719 BACKGROUND

• Schlotzer-Schrehardt U, Naumann GO. Ocular and systemic pseudoexfoliation syndrome. Am J Ophthalmol. 2006 May;141(5):921-937. doi: 10.1016/j.ajo.2006.01.047.

  PMID: 16678509 BACKGROUND

• Streeten BW, Gibson SA, Dark AJ. Pseudoexfoliative material contains an elastic microfibrillar-associated glycoprotein. Trans Am Ophthalmol Soc. 1986;84:304-20.

  PMID: 3590474 BACKGROUND

• Viso E, Rodriguez-Ares MT, Gude F. Prevalence of pseudoexfoliation syndrome among adult Spanish in the Salnes eye Study. Ophthalmic Epidemiol. 2010 Mar;17(2):118-24. doi: 10.3109/09286581003624970.

  PMID: 20302433 BACKGROUND

• Kristianslund O, Ostern AE, Raen M, Sandvik GF, Drolsum L. Does cataract surgery reduce the long-term risk of glaucoma in eyes with pseudoexfoliation syndrome? Acta Ophthalmol. 2016 May;94(3):261-5. doi: 10.1111/aos.12945. Epub 2016 Jan 9.

  PMID: 26749122 BACKGROUND

• Chen PP, Lin SC, Junk AK, Radhakrishnan S, Singh K, Chen TC. The Effect of Phacoemulsification on Intraocular Pressure in Glaucoma Patients: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Jul;122(7):1294-307. doi: 10.1016/j.ophtha.2015.03.021. Epub 2015 May 2.

  PMID: 25943711 BACKGROUND

• Moghimi S, Johari M, Mahmoudi A, Chen R, Mazloumi M, He M, Lin SC. Predictors of intraocular pressure change after phacoemulsification in patients with pseudoexfoliation syndrome. Br J Ophthalmol. 2017 Mar;101(3):283-289. doi: 10.1136/bjophthalmol-2016-308601. Epub 2016 Jun 8.

  PMID: 27281754 BACKGROUND

• Vazquez-Ferreiro P, Carrera-Hueso FJ, Poquet Jornet JE, Fikri-Benbrahim N, Diaz-Rey M, Sanjuan-Cervero R. Intraoperative complications of phacoemulsification in pseudoexfoliation: Metaanalysis. J Cataract Refract Surg. 2016 Nov;42(11):1666-1675. doi: 10.1016/j.jcrs.2016.09.010.

  PMID: 27956295 BACKGROUND

• Shingleton BJ, Neo YN, Cvintal V, Shaikh AM, Liberman P, O'Donoghue MW. Outcome of phacoemulsification and intraocular lens implantion in eyes with pseudoexfoliation and weak zonules. Acta Ophthalmol. 2017 Mar;95(2):182-187. doi: 10.1111/aos.13110. Epub 2016 May 27.

  PMID: 27230126 BACKGROUND

• Astrom S, Stenlund H, Linden C. Intraocular pressure changes over 21 years - a longitudinal age-cohort study in northern Sweden. Acta Ophthalmol. 2014 Aug;92(5):417-20. doi: 10.1111/aos.12232. Epub 2013 Jul 31.

  PMID: 23902137 BACKGROUND

• Mitchell P, Wang JJ, Hourihan F. The relationship between glaucoma and pseudoexfoliation: the Blue Mountains Eye Study. Arch Ophthalmol. 1999 Oct;117(10):1319-24. doi: 10.1001/archopht.117.10.1319.

  PMID: 10532440 BACKGROUND

• Chang RT, Shingleton BJ, Singh K. Timely cataract surgery for improved glaucoma management. J Cataract Refract Surg. 2012 Oct;38(10):1709-10. doi: 10.1016/j.jcrs.2012.08.030. No abstract available.

  PMID: 22999597 BACKGROUND

• Pohjalainen T, Vesti E, Uusitalo RJ, Laatikainen L. Intraocular pressure after phacoemulsification and intraocular lens implantation in nonglaucomatous eyes with and without exfoliation. J Cataract Refract Surg. 2001 Mar;27(3):426-31. doi: 10.1016/s0886-3350(00)00691-x.

  PMID: 11255056 BACKGROUND

• Ekstrom C, Botling Taube A. Pseudoexfoliation and cataract surgery: a population-based 30-year follow-up study. Acta Ophthalmol. 2015 Dec;93(8):774-7. doi: 10.1111/aos.12789. Epub 2015 Jun 11.

  PMID: 26095907 BACKGROUND

• Mamalis N. Exfoliation syndrome: effects of cataract surgery on glaucoma. J Cataract Refract Surg. 2008 Nov;34(11):1813-4. doi: 10.1016/j.jcrs.2008.09.002. No abstract available.

  PMID: 19006713 BACKGROUND

• Vazquez-Ferreiro P, Carrera-Hueso FJ, Fikri-Benbrahim N, Barreiro-Rodriguez L, Diaz-Rey M, Ramon Barrios MA. Intraocular lens dislocation in pseudoexfoliation: a systematic review and meta-analysis. Acta Ophthalmol. 2017 May;95(3):e164-e169. doi: 10.1111/aos.13234. Epub 2016 Aug 29.

  PMID: 27569700 BACKGROUND

• Jakobsson G, Zetterberg M, Lundstrom M, Stenevi U, Grenmark R, Sundelin K. Late dislocation of in-the-bag and out-of-the bag intraocular lenses: ocular and surgical characteristics and time to lens repositioning. J Cataract Refract Surg. 2010 Oct;36(10):1637-44. doi: 10.1016/j.jcrs.2010.04.042.

  PMID: 20870107 BACKGROUND

• Shingleton BJ, Laul A, Nagao K, Wolff B, O'Donoghue M, Eagan E, Flattem N, Desai-Bartoli S. Effect of phacoemulsification on intraocular pressure in eyes with pseudoexfoliation: single-surgeon series. J Cataract Refract Surg. 2008 Nov;34(11):1834-41. doi: 10.1016/j.jcrs.2008.07.025.

  PMID: 19006727 BACKGROUND

• Zetterstrom C, Behndig A, Kugelberg M, Montan P, Lundstrom M. Changes in intraocular pressure after cataract surgery: analysis of the Swedish National Cataract Register Data. J Cataract Refract Surg. 2015 Aug;41(8):1725-9. doi: 10.1016/j.jcrs.2014.12.054.

  PMID: 26432131 BACKGROUND

• Poley BJ, Lindstrom RL, Samuelson TW, Schulze R Jr. Intraocular pressure reduction after phacoemulsification with intraocular lens implantation in glaucomatous and nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and open-angle glaucoma. J Cataract Refract Surg. 2009 Nov;35(11):1946-55. doi: 10.1016/j.jcrs.2009.05.061.

  PMID: 19878828 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.

  PMID: 27800269 BACKGROUND

• Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.

  PMID: 22169081 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

MeSH Terms

Conditions

Exfoliation Syndrome

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, MD

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 11, 2018
• Study Start: May 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 28, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)