Correction of Refractive Error Surprises After Cataract Surgery in Adults

NCT06379477 | Not Yet Recruiting

• 1 other identifier: refractive error surprises
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery.

Conditions

Refractive Errors

Keywords

refractive error surprises

Outcome Measures

Primary Outcomes (1)

• Diagnosis and treatment of the resulting refractive error surprises

  Rate of refractive error surprises

  Baseline

Study Arms (3)

Corneal refractive surgery

ACTIVE COMPARATOR

Among patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises.

Procedure: Refractive surgeries

IOL exchange

ACTIVE COMPARATOR

Among patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises.

Procedure: Refractive surgeries

Piggyback sulcus IOL

ACTIVE COMPARATOR

Among patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises.

Procedure: Refractive surgeries

Interventions

Refractive surgeries PROCEDURE

after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

Corneal refractive surgery; IOL exchange; Piggyback sulcus IOL

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients scheduled for cataract surgery with:
• Symptomatizing patients with postoperative spherical error of more than 1 diopters.
• Symptomatizing patients with postoperative cylindrical error of more than 1 diopters.
• Symptomatizing patients with uncorrected distant visual acuity less than 6/24
• Symptomatizing patients with corrected distant visual acuity of less than 6/12
• Clear cornea. 6. Uneventful surgery.

You may not qualify if:

• Patients with complicated cataract.
• Raised intraocular pressure (IOP).
• Patients with pathologies of the posterior segment of the eye.
• Other causes of diminution of vision.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Abdelghany AA, Alio JL. Surgical options for correction of refractive error following cataract surgery. Eye Vis (Lond). 2014 Oct 16;1:2. doi: 10.1186/s40662-014-0002-2. eCollection 2014.

  PMID: 26605349 BACKGROUND

• Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.

  PMID: 25679413 RESULT

• Gale RP, Saldana M, Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomes after NHS cataract surgery. Eye (Lond). 2009 Jan;23(1):149-52. doi: 10.1038/sj.eye.6702954. Epub 2007 Aug 24.

  PMID: 17721503 RESULT

• Khoramnia R, Auffarth G, Labuz G, Pettit G, Suryakumar R. Refractive Outcomes after Cataract Surgery. Diagnostics (Basel). 2022 Jan 19;12(2):243. doi: 10.3390/diagnostics12020243.

  PMID: 35204334 RESULT

• Moshirfar M, Thomson AC, Thomson RJ, Martheswaran T, McCabe SE. Refractive enhancements for residual refractive error after cataract surgery. Curr Opin Ophthalmol. 2021 Jan;32(1):54-61. doi: 10.1097/ICU.0000000000000717.

  PMID: 33122488 RESULT

• Ladas JG, Stark WJ. Improving cataract surgery refractive outcomes. Ophthalmology. 2011 Sep;118(9):1699-700. doi: 10.1016/j.ophtha.2011.05.038. No abstract available.

  PMID: 21889661 RESULT

• Iwase T, Tanaka N, Sugiyama K. Postoperative refraction changes in phacoemulsification cataract surgery with implantation of different types of intraocular lens. Eur J Ophthalmol. 2008 May-Jun;18(3):371-6. doi: 10.1177/112067210801800310.

  PMID: 18465719 RESULT

MeSH Terms

Conditions

Refractive Errors

Interventions

Refractive Surgical Procedures

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Magdy M Mostafa, MD

  Assiut University

  STUDY DIRECTOR

• Mohamed S Hussien, MD

  Assiut University

  STUDY DIRECTOR

• Ali N Ryad, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman M Saad, MSC

CONTACT

+201067895256; arabasdm.23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ophthalmology specialist at ophthalmology department Assiut University hospital

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 23, 2024
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04